MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM; TEMPLATE

Catalog Number 03.802.000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that during an anterior lumbar interbody fusion procedure, the trial handle broke off from the actual trial.There was a surgical delay of ten to fifteen minutes.The surgery was successfully completed using a different device.The patient outcome post-surgery is good.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a device history review was conducted.The report indicates that no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: product investigation evaluation: one trial spacer handle (part 389.151 lot 57933) along with one trial spacer (03.802.000 lot 2162106) was returned together with a complaint description of ¿during an anterior lumbar interbody fusion procedure, the trial handle broke off from the actual trial.¿ the two parts are used together for stand-alone anterior lumbar interbody fusion procedures indicated for patients with degenerative disc disease.Indications are provided to use pre-operative planners for proper parts selection as well as step by step explanations are described including recommendations and precautions.A trial spacer may be used as a template to facilitate the selection of the trial implant.A trial spacer handle is attached and controlled light hammering on the handle may be applied to advance the trial spacer into the disc space.The returned device (lot 57933) was released to the warehouse in october 2006.The trial spacer handle was received with the tip of the spindle assembly broken off and embedded in the orifice of the trial spacer (03.802.000).The associated drawings for the handle were reviewed; both from the time of manufacture of the returned instrument and the most recent revision.The drawings detail the appropriate dimensions, materials, and finishing process for a successful instrument.Synthes built the failed component for this instrument to a previous drawing.This drawing calls out stainless steel 440a which was changed to custom 465 as it is stronger.In addition, the drawings for the trials were reviewed.The drawings call out the appropriate thread and thread depth to fully seat the spindle assembly; additionally no changes or issues were identified with material and finishing processes for a successful trial spacer device design.This complaint failure could have been caused by improper technique (use of handle in loosened state, excessive impaction force, cross threading) leading to the fracture of the trial spacer handle spindle tip.A design change to the spindle subassembly was implemented to address the breakage of the distal tip of the spindle prior to the manufacturing of this lot.As this instrument was manufactured prior to the design changes the complaint is confirmed and deemed valid from a design perspective.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4366795
• MDR Text Key: 5111883
• Report Number: 9612488-2014-10588
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.802.000
• Device Lot Number: 2162106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR