RAPIDSORB IPS In-Service Presentation 10.11.16synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...

RAPIDSORB® INJECTABLE POLYMER SYSTEM (IPS)

IN-SERVICE PRESENTATION

DSUS/BIO/0816/0096b 10/16 © DePuy Synthes 2016. All rights reserved.

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Drill and fill resorbable fixation.

• RAPIDSORB® Injectable Polymer System (IPS) is a novel fixation system featuring a cordless delivery device, selectable fastener length, rapid-shot functionality, and an easy to follow technique.

• RAPIDSORB IPS is an alternative to resorbable screws and is designed to complement the 1.5 mm RAPIDSORB Rapid Resorbable Fixation System.

• The handheld delivery device accepts sterile Fastener Cartridges, which are equivalent to a multi pack of screws. The RAPIDSORB IPS delivery device heats and delivers polymer to the implantation site, creating a fastener in-situ.

RAPIDSORB Injectable Polymer System (IPS)


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RAPIDSORB IPS | Polymer

• Same polymer used in RAPIDSORB System plates, sheets, meshes and screws

• Copolymer formed by combining L-lactide and glycolide

• 85% L-lactide – characterized by high strength and long degradation time

• 15% Glycolide –characterized by lower strength and more rapid degradation


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RAPIDSORB System | Science

• The RAPIDSORB System polymer resorbs in a period of about 12 months by bulk hydrolysis

• In bulk hydrolysis the polymer is broken down into acids by water in the body

• These acids are eliminated through natural body metabolism in the form of CO2 and H2O

• The RAPIDSORB System retains approximately 85% of its initial bending strength after 8 weeks1

1. Average Strength Retention File USBIO07003.


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RAPIDSORB System RAPIDSORB IPSThe RAPIDSORB Rapid Resorbable Fixation system is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

In addition, resorbable meshes, sheets, screws, and tacks may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, meshes, and sheets.

In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

Indications*

*Refer to the package inserts for the full list of indications, contraindications, warnings and/or precautions.


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RAPIDSORB IPS is not intended for use in full load bearing applications. These devices are not intended for areas with active or latent infection, limited blood supply, or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

RAPIDSORB System RAPIDSORB IPS

These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The RAPIDSORB Rapid Resorbable System is not intended for areas with active or latent infection, or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

Contraindications*

*Refer to the package inserts for the full list of indications, contraindications, warnings and/or precautions.


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• When:• Craniosynostosis reconstruction,

reconstruction in midface or cranium (excluding upper and lower jaw)

• When temporary fixation is desired• When unrestricted bone growth is required

• Why:• Resorbs in approximately 12 months• Radiolucent material does not interfere with

radiographic imaging • Provides sufficient strength during initial

healing phase

RAPIDSORB IPS | Applications

CraniosynostosisReconstruction /

Cranial Vault Remodeling


FEATURES & BENEFITS


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RAPIDSORB IPS | Features & Benefits

• Reduces hand-offs for reloading• No picking up screws or pins • Produce approximately 20 fasteners at 4 mm length

with large Fastener Cartridge

Fastener Cartridge

• Reduces carrying fastener inventory• Less hand-offs in surgery• Adjust fastener length by Fastener Length Dial – no

need to open another pack of screws or pins

Adjustable lengths on demand

• No cords or foot pedalBattery-Operated

• Proven polymer (85:15 poly (L-lactide-co-glycolide) with low inflammatory response

• RAPIDSORB System polymer has been on the market since 2003

Proven Polymer


SYSTEM OVERVIEW


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• All visible parts are provided sterile and are disposable

RAPIDSORB IPS | Delivery Device

Device Tip

Fastener Cartridge Port

Push Rod Release Lever Push Rod

Fastener Length Dial

Battery Pack

Activation Button


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• The back of the device contains icons and symbols that illuminate on the back of the device that notifies the user if the device requires attention.

RAPIDSORB IPS | Icons on Back of Device

Standby

Ready

Heating

Caution/Fault

Low Battery

Low Polymer

Fastener Length Fastener Length Dial


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RAPIDSORB IPS | Disposable Components

Delivery Device Starter Kit

Battery Pack Fastener Cartridge

Drill Bits Replacement Cap


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• RAPIDSORB IPS Delivery Device Starter Kit contains• Device Shell • Device Cap• Starter Fastener Cartridge –

produces approximately 15 fasteners at 4 mm length

• Reference Card

RAPIDSORB IPS | Delivery Device Starter Kit


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• Doubled-sided card to aid in device assembly and priming

• Sterile packed in each Starter Kit

RAPIDSORB IPS | Reference Card


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RAPIDSORB IPS | Battery Pack - Sterile

• Single-use lithium battery specific to RAPIDSORB IPS

• Important: • To maximize battery life, RAPIDSORB IPS should be

assembled and powered up about 15 minutes prior to its use.

• Alternatively, RAPIDSORB IPS can be assembled and primed at the start of the case then the battery removed to conserve battery life. About 5 minutes before use the Battery Pack should be inserted and warmed to its Ready state.

• Battery Packs must ship via ground. Please plan accordingly. Battery Packs have 5 year shelf life.


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Small Fastener Cartridge

• Approximately 5 fasteners at 4 mm length

• 805.505.01S

Medium Fastener Cartridge


• 805.510.01S

Large Fastener Cartridge


• 805.520.01S

RAPIDSORB IPS | Fastener Cartridges

• All fastener cartridges appear the same, but contain different amounts of polymer


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RAPIDSORB System Temperature Dot RAPIDSORB IPS Temperature Dot

RAPIDSORB IPS | Temperature Sensitive

New temperature dots trigger at a lower temperature, 104F (40C).

IF TEMPERATURE INDICATOR IS BLACK

DO NOT USE

Product okay to use


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• Specific to RAPIDSORB IPS, 1.7 mm diameter• Provided sterile• 3 mm – 8 mm

RAPIDSORB IPS | Drill Bits

310.403S 1.7 mm Drill bit w/ 3 mm stop, J-latch for RAPIDSORB IPS – Sterile





310.408S 1.7 mm Drill bit w/ 8 mm stop, J-latch for RAPIDSORB IPS - Sterile


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• A Replacement Cap is also available • To be used if cap sterility is compromised during device assembly• Replace cap without having to open a new RAPIDSORB IPS Delivery

Device Starter Kit

RAPIDSORB IPS | Replacement Cap


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Non‐sterile

Power Drive Unit

Sterility Shield (Remove before applying cap)

Sterility Shield

Power Drive Unit

RAPIDSORB IPS | Non-Disposable Components


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• Used to insert non-sterile Power Drive Unit into Delivery Device Shell

• Sterilized after each case• Ensure Sterility Shield is not

thrown away or lost • Etched with RAPIDSORB IPS• A backup Sterility Shield should

always be available for cases in the event that the Power Drive Unit needs to be replaced

RAPIDSORB IPS | Sterility Shield


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• Software-enabled • DO NOT STERILIZE• At the end of the case:

• Wiped down • Placed back in Power Drive

Unit Case• Ensure unit is not throw away

at the end of the case!• 1 year maintenance schedule

RAPIDSORB IPS | Power Drive Unit


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RAPIDSORB IPS For each case:

*A backup Power Drive Unit, Sterility Shield and Delivery Device Starter Kit should be available for all procedures.

Power Drive Unit*

Sterility Shield

Disposable items

Delivery Device Starter Kit*

Battery Pack (sterile)

RAPIDSORB IPS Drill Bit

Fastener Cartridge


TECHNIQUE OVERVIEW


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RAPIDSORB IPS DELIVERY DEVICERAPIDSORB IPS DELIVERY DEVICE

Please see the RAPIDSORB Injectable Polymer System (IPS) Technique Guide (DSUS/BIO/0516/0092) for all technique information.


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In preparation for fixating RAPIDSORB System plates, meshes, or sheets using RAPIDSORB IPS, preoperative assembly is required. To prevent contamination during assembly, a sterile (scrubbed) person and a non-sterile (circulating) person are required. All steps are completed by the sterile (scrubbed) person unless otherwise noted.

What you need to assemble RAPIDSORB IPS:805.550.01S RAPIDSORB IPS Delivery Device Starter Kit - Sterile530.551 RAPIDSORB IPS Power Drive Unit530.553.01S RAPIDSORB IPS Battery Pack – Sterile530.554 RAPIDSORB IPS Sterility Shield

ASSEMBLYASSEMBLY


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Press Push Rod Forward until it stops

Push Rod

1 32Position

Sterility Shield over opening

Circulating Person –Insert Power Drive

Unit by aligning orange indicators

ASSEMBLY INSTRUCTIONSASSEMBLY INSTRUCTIONS


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Place Cap over Power Drive

Unit

4Turn Cap

clockwise to lock position

5Insert

Battery Pack

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Icons light up on back

of the device.

Device is in Standby.

ASSEMBLY INSTRUCTIONS (continued)ASSEMBLY INSTRUCTIONS (continued)


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Press Release Lever forward and pull back

Push Rod until etched ring is

visible

1Insert tip of Fastener

Cartridge into Fastener Cartridge Port and push

ribbed portion of Fastener Cartridge forward until

polymer is transferred into the device

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Discard empty Fastener Cartridge.

Advance the Push Rod until

it stops

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LOAD FASTENER CARTRIDGELOAD FASTENER CARTRIDGE


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The quantity of fasteners produced will vary depending on length of fasteners being implanted. The fastener length can be adjusted with the Fastener Length Dial on the device Cap. See the table below for approximate quantities.

Note: If reloading the device with additional Fastener Cartridges, please table on page 15 of the RAPIDSORB IPS Technique Guide (DSUS/BIO/0516/0092) for fastener quantities.

STARTER CARTRIDGE FASTENER PRODUCTIONSTARTER CARTRIDGE FASTENER PRODUCTION

Approx. Quantity of Fasteners Produced By Starter Cartridge* After Device is Primed

Fastener Length 3 mm 4 mm** 5 mm 6 mm 7 mm 8 mm

Approx. Quantity of Fasteners 17 15 12 11 9 8*Starter Cartridge is included in the RAPIDSORB IPS Delivery Device Starter Kit**4 mm is the most common length


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INTRAOPERATIVE POLYMER RELOADINGINTRAOPERATIVE POLYMER RELOADING

Approx. Quantity* of Fasteners Produced By Fastener Cartridges When Reloading

Fastener Length 3 mm 4 mm** 5 mm 6 mm 7 mm 8 mm

805.505.01S – Small FastenerCartridge

5 5 4 3 3 2

805.510.01S – Medium Fastener Cartridge

12 10 8 7 6 6

805.520.01S – Large Fastener Cartridge

25 21 18 15 13 12

*The quantities are accurate when reloading a device that has previously been used to insert fasteners**4 mm is the most common length

Additional Fastener Cartridges may be added to refill the device with polymer if required to complete the procedure. The Low Polymer icon will be illuminated to indicate when additional polymer is needed. See table below for guidance on choosing Fastener Cartridge size according length and quantity of fasteners required.


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• Press and release Activation Button to bring device out of Standby and start heating

• Ready Icon will illuminate when device is up to temperature

Heat Device

• Press and release Activation Button to start fastener formation cycle

• Repeat until polymer is expelled from the tip

Press Activation Button

• Remove excess polymer with sterile gloved fingertips and discard

• Caution: Avoid prolonged contact with the tip, as surface temperature may reach 100C

Remove excess polymer

PRIME DEVICEPRIME DEVICE


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• Drill bit perpendicular to bone• Irrigation is recommended• Do not damage plate

• An optional bolus of polymer can be created on the underside of the bone by selecting a longer length fastener.

• Hold device perpendicular

• Press Activation Button• Remove device after Ready

icon blinks 4 times

Drill hole through plate

Choose Fastener length

Align tip through plate and into hole

Insert Fastener

TECHNIQUE OVERVIEWTECHNIQUE OVERVIEW


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FORMING FASTENERSFORMING FASTENERS

Optional bolus examples:

3 mm Fastener Length in 2 mm

bone


bone


bone


bone


bone


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FASTENER TROUBLESHOOTINGDescription Remedy

Normal Head N/A

Inadequate pressure Hold against plate with more force (use light pressure against plate)

Early pull-off Wait for the “READY” icon to flash 4 times before pulling off

Too much pressure Hold against plate with less force (use light pressure against plate)

Lateral movement Hold device steady and axially in line with hole during formation


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RAPIDSORB IPS Technique Tips!

• To maximize battery life, RAPIDSORB IPS should be assembled and powered up about 15 minutes prior to its use. It can also be assembled at the start of the case and then the Battery Pack removed to conserve battery.

• If icons on the back of the device do not illuminate when the battery is inserted, be sure that the cap is fully locked (turn clockwise).

Maximize Battery Life

• Only insert a new Fastener Cartridge if the Low Polymer Icon is illuminated.• Be certain that the Push Rod is fully pulled back and etched ring is visible before

adding polymer.• Be careful not to push the Activation Button during reloading process.• Ensure Fastener Cartridge is fully collapsed after loading polymer.

Loading Fastener Cartridges

• Apply light pressure so that the tip of the device does not lift from the plate• The Ready Icon indicates when the fastener formation cycle is complete. The

Ready Icon will blink 4 times and will then remain on when the fastener has been formed.

Fastener Insertion


STUDY RESULTS


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RAPIDSORB IPS | Animal Study Results

• Sheep study• No evidence of thermal

necrosis • Demonstrated comparable

biocompatibility, irritancy scores and healing in comparison to the RAPIDSORB Rapid Resorbable Fixation System and KLS Martin’s SonicWeld Rx System


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RAPIDSORB IPS | Shear Strength Data

0

20

40

60

80

100

120

140

160

0 Wk 2 Wk 4 Wk 8 Wk 12 Wk

New

tons

(N)

Shear Strength ComparisonInvitro Test Data

1.5mm RAPIDSORB IPS Fasteners 8mm – Sterile 1.5 x 6mm Direct Drive Lactosorb Screws-Sterile

1.5mm RAPIDSORB System Screws 8mm-Sterile 1.6 x 6mm KLS Martin Resorb x SonicPins RX -Sterile

ReferenceMechanical Test Lab TestMT13-072 and MT13-155


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RAPIDSORB IPS | Axial Pullout Data

0

10

20

30

40

50

60

70

0 Wk 2 Wk 4 Wk 8 Wk 12 Wk

New

tons

(N)

Axial PulloutInvitro Test Data

1.5mm RAPIDSORB IPS Fasteners 4mm-Sterile 1.5 x 3mm Direct Drive Lactosorb Screw-Sterile

1.5mm RAPIDSORB System Screw 4mm-Sterile KLS Martin Resorb x SonicPins RX 1.6 x 4 mm Sterile

Reference:Mechanical Test Lab TestMT13-071 and MT13-156


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Time Study Results | Time to Insert a Fastener/Pin/Screw

0 5 10 15 20 25 30 35 40

RAPIDSORB IPS

RAPIDSORB System

LactoSorb

SonicWeld Rx

Seconds/ Successful Fastener

Average Tef

Results show that the Tef for the RAPIDSORB IPS and SonicWeld were comparable (a difference of 0.71 seconds per successful fastener), and the times for those two systems being about half that of the LactoSorb and RAPIDSORB System.


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Time Study Results | Average Procedure Times – 20 Fasteners/Pins/Screws

0.00 100.00 200.00 300.00 400.00 500.00 600.00 700.00 800.00 900.00Seconds

Average Overall Time

LactoSorbSonicWeld RxRAPIDSORB SystemRAPIDSORB IPS


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Time Study Results – Less Product Waste

System Replaced Fasteners

Adjusted Fasteners

RAPIDSORB IPS 0 N/ARAPIDSORB System 7 1

LactoSorb 14 12SonicWeld Rx 10 12

• Fasteners are considered replaced fasteners if the original fastener that was used to fix the plate was damaged in a way that the old fastener needed to be drilled out and an emergency kit needed to be utilized.

• Overall the LactoSorb system experienced the highest amount of replaced fasteners across all participants (n=14), while none of the RAPIDSORB IPS fasteners needed to be replaced.

• Overall the LactoSorb and SonicWeld Rx systems experienced the highest amount of adjusted fasteners across all participants (n=12), while RAPIDSORB System only needed 1 fastener to be adjusted.


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Time Study Results – NASA Task Load Index

0

20

40

60

80

100

Mental Demand Phyiscal Demand Temporal Demand Performance Effort Frustration

RAPIDSORB IPS SonicWeld Rx RAPIDSORB System LactoSorb

Mental Demand - How mentally demanding was the task?Physical Demand - How physically demanding was the task?Temporal Demand - How hurried or rushed was the pace of the task?Performance - How successful were you in accomplishing what you were asked to do?Effort - How hard did you have to work to accomplish your level of performance?


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Time Study Results – NASA Average Workload

0

20

40

60

80

100

Overall Workload

RAPIDSORB IPS SonicWeld Rx RAPIDSORB System LactoSorb

**

*

*

*


QUESTIONS?


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RAPIDSORB IPS In-Service Presentation 10.11.16synthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes...

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