after Prof. Dr. Labitzke

Instructions for cleaning and sterilization Surgical instructions for humerus, tibia and femur fractures in adults and children

0481

DIN EN ISO 13485

Instruction Manual

2

0481

DIN EN ISO 13485

The BONEHELIX® impant may only be used by experiencedsurgeons (specialists) who have received training in BONEHELIX®

technology. Before using this implant, the surgeon is required toread the following guidelines and instructions, supplementary tothe information provided on the product label.

The product is delivered in an non-sterile condition, and must becleaned and sterilized before use. Users are required to followthe cleaning and sterilization instructions.

General Safety Instructions1. H&R Implants are manufactured in accordance with the latestresearch and discoveries in implantation technology, as well as accepted regulations. However, their safety and functionality can only be ensured if these instructions are closely observedby the surgeon.

2. The surgeon needs to be familiar with all BONEHELIX®

implantation processes.3. Complications which may arise from incorrect indication, surgical technique or asepsis are the responsibility of the surgeon and cannot be attributed to the manufacturer or supplier of the products.

BONEHELIX® Implants are only for healing, and are not a sub-stitute for intact tissue and bone material. The anatomy ofhuman bone places limits on the size of implants to be used.

Product DescriptionThe BONEHELIX® is a limited flexibility, medullary cavity stabilizerfor shaft fractures in long bones, developed by Prof. R. Labitzke.The BONEHELIX® Implant is manufactured from surgical implantsteel 1.4441 and complies with the requirements of DIN EN 5832-1.

IndicationIndicators for the BONEHELIX® Implant are shaft fractures inlonger long bones in the 2nd to 4th sixth. Mainly oblique andshort angled fractures, including fractures with smaller bendingwedges or fragmentation on the upper arm (humerus) and lowerleg (tibia) can be stabilized. To be noted is where the primaryrestoration of anatomy (that is, the tubular shape of the bones)was performed with cerclages in long slant and bend fracturesof AO types A, B, C, with and without rotary flexure wedges. Thisis the only way the Helix obtain enough grip in the medullarycavity.

Since there is still no CE certification of the BONEHELIX® forthe adult femur, it can only be implanted here as a 'special application as prescribed by a doctor'.

Contra-indicators and side effectsThe Helix must not be used on subcapital or joint fractures ofthe 1st, 5th and 6th sixths. Fractures near joints in the shoulderand elbow as well as the tibia and femur are contra-indicators.

Inserting the Helix at an oblique angle can lead to hooking onthe counter-corticalis. A Helix which is too short or too thin canlead to pseudo arthrosis (non-unions). Long oblique fracturesof AO types A, B and C without cerclages are contra-indicated.

If there is any doubt, seilcerclages must be applied to restorethe tubular shape of the bone. This guarantees the internalstrength of the helices.

Storage and Treatment of the Implants Implants are highly susceptible to damage. Extreme careneeds to be taken when working with them:

• Products should be stored, unopened, in their original packaging.

• Protective packaging may only be removed immediately prior to sterilization.

• Implants must not be mechanically or otherwise altered unless this is expressly provided in the design and operatinginstructions. In the event of any doubt, a written recommen-dation from the manufacturer must be obtained.

• Under no circumstances may obviously damaged, scratched, incorrectly treated implants that have been used before, or implants that have been modified without authorization, be used.

Cleaning and Sterilization before usePlease observe the cleaning and sterilization instructions.

IMPORTANT!Patients who receive these implants must be advised that thesafety and life of the implant depend on the following factorsand risks:

• the patient’s weight

• extreme loading to be expected from work and sport

• epilepsy or other causes of repeated accidents with increased fracture risk

• significant osteoporosis or osteomalacia

• weakening of supporting structures caused by tumours

• allergy to any material components of the implants

Materials usedImplant Steel 1.4441

Instructions for surgery1. The operation must be planned precisely on the basis of the radiography findings.

2. When unpacking the implant, check that it conforms with the label on the packaging, and ensure that the implant has been handled correctly.

For exact surgical instructions see pages 4-11

Post-operative care

• Mobilization and follow-up are the responsibility of the surgeonand must be determined by the needs of the patient

• The osteosyntheses are suited to exercise and partial loading

• The patient should be advised that the implant must be checkedin the event of extreme falls or blows.

Instructions

3

0481

DIN EN ISO 13485

Cleaning and sterilization instructions

The BONEHELIX® implant is hereinafter referred to as the im-plant.

WarningThe implant is supplied in an non-sterile condition and must betreated according to the instructions below prior to use.

Restrictions on reprocessingThe implant is intended for single use. It is not intended forreuse/reprocessing.

InstructionsAt the place of useThe delivery packaging is not suitable for sterilization. The implantmust be inspected for damage and surface contamination beforeuse. Dirt should be removed with a lint-free disposable paper towel.

Storage and Transport No special requirements.

Preparation for CleaningNo special requirements.

Manual CleaningNot recommended

Automated CleaningRecommended!During automated cleaning the guidelines of the respectivemanufacturers must be followed. Check the implant for visibledirt during unpacking. If necessary, pre-clean manually.

We recommend the following procedure:a) Manual pre-cleaningImmerse the implant in non-fixing detergent and disinfectantaccording to the manufacturers’ specifications. Brush off theimplant with a soft nylon brush until no more dirt is visible.

Rinse thoroughly in cold water to remove all trace of detergentand disinfectant

b) Automatic cleaning and disinfection Disinfector: Miele Disinfector G 7835 CD

• Cleaning program “Des-Var-TD“

• 2 minute pre-wash in cold tap water

• Cleaning with Neodic® (alkaline) Mediclean forte, 0.5% by Dr. Weigert: 5 minutes, 55 ° C ± 5 °

• Neutralization (Neodisher® Z): 2 minutes, 10 ° C

• Washing/rinsing: 1 minute, 10 °C, de-ionized water

• Thermal disinfection: 5 minutes, > 90 °C (A0 value > 3000)

• Drying: 25 minutes, 60 °C ± 5 °C

Monitoring and function testingVisual inspection for damage and wear. Damaged or dysfunctionalimplants may not be used.

PackaagingStandardized packaging material (medical devices) can be used.The pouch should be large enough for the instrument, so thatthe seal is not stressed.

SterilizationSteam sterilization at 134° C, 5 minutes; Class B sterilizer (EN13060), fractionated pre-vacuum method, 2 vacuum stages.Follow the instructions of the sterilizer manufacturer with respectto loading, handling and drying times.

If there has been pathogen contamination which cannot be eli-minated by the sterilization procedure, the implant may not beused.

StoragePack and store in dry, dust- and bacteria-proof sterilizationpouches.

Additional informationDuring sterilization of multiple implants and instruments in a steri-lization cycle the maximum sterilizer load may not be exceeded.

It is the responsibility of the user to ensure that the actual cleaningand sterilization with the equipment, materials and personnel avai-lable in the facility achieves the desired results.

This usually requires validation and routine monitoring of theprocess.

Similarly, any deviation from the instructions provided by the producer should be carefully evaluated for effectiveness and potential adverse effects.

Rev.-Stand: 11.08.2015

4

0481

DIN EN ISO 13485

Selection of the BONEHELIX® to be implanted.H-Helices are generally 28 cm long. Radiography images areused to measure the narrowest section of the humerus diaphysis.The Helix selected should be 1 mm narrower.Example: Diaphysis 10 mm - Helix 9 mm = H1

At the same time, the length of the Helix should be determined.It should be sized to about 1 (-2) QF above the olecranon fossa:this is not detrimental, but reduces the risk of having to replacethe Helix due to accidental excess length. Since all humerusHelix heads measure 12 mm, the bone access points must bedrilled so far that they can be sunk down to the vertical spur,thus excluding any impingements.

RecommendationProximal shaft fractures in the 2nd to 3rd sixth can be stabilisedusing antegrade distal treatment. Shaft fractures are best treatedretrograde in a prone position.

Proximal accessSurgery in beach chair positionForearm positioned on holder. C-Arm homolateral3 - 5 cm dorso-ventral suspensory incision 1 cm lateral to theacromion. Split the deltoid muscle in the fibre direction, 1 cmshort longitudinal section through the rotator cuff tendon abovethe collum anatomicum at the level of the greater tuberosity.Skin and tendon incision are 90° to each other.

Figure 1Drill a 12 mm hole in the collum anatomicum using a cone-shaped awl in a strictly axial direction without touching thehead cartilage. This will enable the guide rod and helix to followthe medullary canal without getting caught.

Figure 2In a dislocation ad axim, the curved tip repositioning rod isuseful. After introduction in line with the axis, a thin guide rod,held with forceps, is introduced beside the repositioning rod inboth planes of the distal radius fragment, under X-ray control.Now the repositioning rod may be withdrawn. While the roundednail centers itself, the path into the distal main fracture piecefor the Helix, which works like a screw, must be opened bystrictly axial alignment of both major fragments. To this end itis essential that both fragments are manually repositioned witha guide rod, under X-ray control, so precisely that the proximaland distal corticalis are directly opposite each other and anyaxial bend is avoided. If this doesn’t work, the Helix cannot"thread" the distal fragment; it will instead connect with thecorticalis. If it is closed and, while pulling on the forearm, it isnot possible to guide the Helix into the distal fragment, an openrepositioning may be required, as an exception, by making asmall lateral incision. The Helix tip can inserted visually into thedistal bone canal without a repositioning rod.

Figure 3Now the radiologically presized and suitably shortenedBONE HELIX® can be screwed in with the guide rod, using theT-ratchet. Rounded flat-nose forceps are used, at two helix turns,to prevent the Helix from being carried along to the distal frag-ment. Inspection is conducted by radiography before reachingthe distal fragment. The fracture surfaces are compressed manually,so that no dehiscence occurs. Repeat X-ray check. After 2 turnsof the Helix into the lower fragment, the guide rod is removed.The Helix is then turned until its head is flush with the bone.Adaptation of the rotator cuff tendon with a subcutaneous sutureand dermal suture.

Distal AccessProne position, upper arm positioned on a radiolucent plate,C-Arm homolateralAccess is best obtained just above or at the arch of the olecranonfossa, through the triceps tendon. Because the corticalis canbe really hard here, it would be beneficial to drill to a depth of12 mm with the medullary drill. The Helix can then be securelysunk here. In the case of a narrow distal medullary cavity, theH0 = C2 = 8 mm Helix has proven to be suitable. If necessary,the distal fragment can be drilled open up to the point wherethe diaphysis measures 9mm.

The repositioning rod is often unnecessary because the bearingplate axially coordinates the fragments. After positioning the guiderod in the proximal fragment, continue as described above; forstability, it is sufficient if the helix tip is a few centimetres sub-capital. Adaptation of the triceps tendon, dermal suture.

Post-treatmentNo external support bandages.

Immediate use of exercise devices and, if free from pain, up tothe horizontal position, steadily increase the load over time.

NoteThe removal of the Helix is only mandatory in children andadolescents, it is optional in (older) adults.

Helix External DiameterH0 = C2 = 8 mmH1 = 9 mmH2 = 10 mmH3 = 11 mm(H4 = 11 mm)

Rev.-Stand: 15.04.2016

Surgical instructions for the humerus

5

0481

DIN EN ISO 13485

Possible dangers: When opening the medullarycanal proximally, the guide rodcould perforate the medial corti-calis, or be bent too much by it.The Helix tip would continuestraight at its strongest curvature,leading to blockage or perforation.

Incorrect!

Figure 1Awl access

Figure 2Repositioning rod

Figure 3Guide rod, as axial as possible

Mainly transverse and shortoblique fractures, as well asfractures with bending wed-ges or fragmentation on thehumerus are stabilized.

6

0481

DIN EN ISO 13485

Selection of the BONEHELIX® to be implanted. T-Helices are generally 38 cm long.

Use a radiography (X-Ray) to measure the narrowest point on theTibia diaphysis. The Helix selected should be 1 mm narrower. Example: Diaphysis 11 mm - Helix 10 mm = T2

At the same time the Helix length is determined. It should beto 1 (-2) QF above the ankle joint. This minimizes the chancethat the Helix will be too long and will have to be exchanged.

Since all Tibia Helix heads measure 13 mm, the bone accesspoints must be drilled out to the same width, so that they canbe inserted on the vertical path. An impingement can thus beavoided.

PositionOperation on hanging lower legC-Arm homolateral

Figure 1Either: cross-section at the upper edge of the tibial tuberosity(cosmetically favourable) or longitudinal section above the patel-lar ligament. Longitudinal split of the ligament and drilled accesswith the cone-shaped awl or with the medullary nail drill abovethe tuberosity under thinning of the ventral tibial cortical bone ina strictly axial direction. The Helix can then follow the medullarycanal without heavy bending, and without snagging or perfora-ting the counter-corticalis.

Or: should you do not wish to split the patellar ligament longitu-dinally, you may gain fibular or fibular-distal access to the tube-rosity, as is the case in children because of the open epiphysis(see page 9).

The hanging position of the lower leg allows a safe axial reposi-tioning when palpating the sharp front tibial edge.

The repositioning rod is often unnecessary. An open insertion ofthe helical tip into the distal fragment is not required.

The guide rod is held with forceps and locked, under X-ray con-trol in two planes, into the distal fragment strictly axially.

Figure 2Now the pre-sized and correspondingly shortened BONEHELIX®

is turned in via the guide rod with the appropriate driver. Roundedflat-nose forceps are used, at two helix turns, to prevent theHelix from being carried along to the distal fragment.

Inspection by radiography before reaching the distal fragment.The fracture surfaces are compressed manually, so that nodehiscence occurs. Repeat X-ray check.

After 2 turns of the Helix into the lower fragment, the guide rodis removed. The helix is then turned until its head is flush withthe bone. The distal end should reach to the ankle if possible.Adaptation of the patellar ligament, dermal suture.

Post-treatmentImmediate use of exercise device ; The high axial stiffness ofthe BONEHELIX® allows measured loading, relative to the break,time and callus, in the walker.No external support bandages.

NotesThe removal of the Helix is only mandatory in children andadolescents, it is optional in (older) adults.

Helix External DiameterT1 = 9 mmT2 = 10 mmT3 = 11 mm

Surgical instructions for the tibial shaft

Figure 1Awl access

7

0481

DIN EN ISO 13485

Possible dangersWhen opening the medullary canal at anangle, the guide rod could perforate the medial corticalis - or be bent too much by it.The Helix tip would continue straight at thestrongest curvature, leading to blockage orperforation.

Incorrect!

Transverse and short oblique fractures,as well as fractures with bending wedgesor fragmentation zones, are stabilized onthe tibia.

Figure 2Guide rod,as axial as possible

8

0481

DIN EN ISO 13485

Figure 1Awl access

Figure 2Guide rod, as axialas possible

Epiphisys Injury

Incorrect!

GeneralHelices for children are, in general, 30 cm long. The particu-larly fine/small C1 Helices were developed for children fromthe age of 6 years. These Helices are also suited to the femur.

Versions C2 and C3 are used for older children, possible thethinnest of the adult Helices.

Helix for children – external diameter C1 = 7 mmC2 = 8 mm = H0C3 = 9 mmC = Children

Surgical instructions for paediatric fractures

Surgical instructions for paediatric humeral shaft

9

0481

DIN EN ISO 13485

Figure 1 Awl access

Figure 2Guide rod, as axialas possible

Epiphysis injury

Incorrect!

Humerus and tibia(Children up to about 14 years)In paediatric shaft fracture of the humerus and tibia, the growthplates which are still open (epiphyses), force the use of modifiedaccess. In both cases enter the greater humeral tuberosity ordistal fibula of the tuberositas tibiae laterally-distally – as shownin Figures 1 and 2 respectively.

Further procedures are the same as for adults – see pp 4 - 7.

Rev.-Stand: 15.04.2016

Surgical instructions for paediatric tibial shaft

10

0481

DIN EN ISO 13485

Figure 1Awl access

Figure 2Guide rod, as axialas possible

C-Helices for children up to 14 years

PositioningPosition on the extension table, spreading of thehealthy leg. C-Arm homolateral

Figure 1UMark the 5 cm incision under image converter control. Follow the length of the greater trochanter proximally. Split theabductors above the trochanter, exposing the proximal roundingof the femoral neck.

Open the femur with the awl directly medial to the trochanter,through the upper corticalis. This positions the surgeon preci-sely over medullary canal cylinder; growth plates are not af-fected here.

Axial repositioning has already been achieved by the extension.This ensures that the guide rod can be introduced without difficulty.

Figure 2The Helix, pre-measured for length and breadth using radiography,is screwed in until neither its head or vertical spike protrudes from

Surgical instruction for paediatric femur shaft fractures

11

Epiphysis injury

Incorrect!

the femoral neck. There is no need to worry about an impinge-ment syndrome in this case. The distal should get the surgeonrelatively close to the femoral condyle. After reaching the distalfragment, shorten the extension.

NoteQuick removal of the Helix, relative to callus formation.

Post-treatmentSituational; movement with measured loading,

Rev.-Stand: 15.04.2016

Do you need to arrange an appointment with someone? You’dlike to organise a presentation, you need training at your roomsor support during surgery? If so, please make contact with ourmarketing team at

vertrieb@hr-medizintechnik.com

For questions relating to the system, customer service is available on

+49 (2721) 9260-99

Contact

Purchase Order Form+49 2721/92 60 98

Name of hospital

Street

City/Zip code

Department

EMail/Phone

Customer ID

Regular shipping Express shipping until_______________

Order numberProduct

Piece Single price

IF22837

BONEHELIX® Typ H1

Euro

IF22838

BONEHELIX® Typ H2

Euro

IF22839

BONEHELIX® Typ H3

Euro

IF22840

BONEHELIX® Typ H4

Euro

IF22841

BONEHELIX® Typ T1

Euro

IF22842

BONEHELIX® Typ T2

Euro

IF22843

BONEHELIX® Typ T3

Euro

IF24881

BONEHELIX® Typ C1

Euro

IF24879

BONEHELIX® Typ C2

Euro

IF24880

BONEHELIX® Typ C3

Euro

MP-W05-009 Forceps 175 mm, modify

Euro

MP-W55-025 Guide rod 400 mm/ø 1,8 mm

Euro

MP-W50-068 Repositioning rod with integrated silicon handle 440 mm

Euro

MP-W46-036 Awl 166 mm

Euro

MP-W23-027 Insertion/removal driver 150 mm

Euro

MP-W32-641 WEB A clutch, T-grip with silicon cover

Euro

MP-W48-008 Small hammer 300 g, 240 mm softgrip Mod. 0

Euro

MP-W01-041 Bolt cutters 450 mm

Euro

MP-W85-141 Perforated basket for Helixes, stainless

Euro

MP-W85-142 Perforated basket for tools, stainless

Euro

MP-W85-021 Steri Container, basis

Euro

MP-W85-027 Cover for Steri Container (592 x 274 mm)

Euro

MP-W85-043 Paper filter Aesculap ø 190 mm, 100 piece

Euro

Prof. Dr. Labitzke

Date/Signature

DIN EN ISO 13485

0481H&R Medizintechnik GmbH & Co. KG · Elsper Straße 36 · 57368 Lennestadt · Germany

T. +49 2721/92 60 99 · F. +49 2721/92 60 98 · vertrieb@hr-medizintechnik.com · www.bonehelix.com Revisions Stand. 01.09.2018DIN EN ISO 13485

The limited flexibility medullary cavity

stabilizer for the treatment of shaft fractures

0481

DIN EN ISO 13485

after Prof. Dr. Labitzke

BEST OF2018

More useful information, available to download, can be found on our website www.bonehelix.com.

0481

DIN EN ISO 13485

after Prof. Dr. Labitzke

Preparation of

instruments

ISO 13485 certified

after Prof. Dr. Labitzke

H&R Medizintechnik GmbH & Co. KG · Elsper Straße 36 · 57368 Lennestadt · Germany

T. +49 2721/92 60 99 · F. +49 2721/92 60 98 · vertrieb@hr-medizintechnik.com · www.bonehelix.com