MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COLLAR POSITIONER FOR DUAL-OPENING IMPL F/6.0MM RODS; PLIERS,SURGICAL

Catalog Number	388.151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a piece of collar positioner "sleeve" broke off during impaction.Instrument will be returned.Unknown if fragments were generated, procedure successfully completed, or if surgery delayed due to the reported event.Concomitant device reported: unknown collar impactor (part#unknown, lot#unknown, quantity#1).This complaint involves (1) device.This report is 1 of 1 for (b)(4).
Event or Problem Description
No fragments were generated from the broken device.Procedure was completed with a second similar device.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: part: 388.151.Lot: 1159723.Manufacturing site: hägendorf.Release to warehouse date: january 30, 2003.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the sleeve positioner f/uss-ii w/integrated was received with the collet broken.The collet handle was broken off from the collet body at the silver brazing.No other issues were identified with the returned components of the device.Dimensional inspection: dimensional inspection was not conducted/irrelevant as the breakage/failure was due to the silver brazing.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.Collar positioner, collet, collet body and - collet handle.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed as the collet on the sleeve positioner f/uss-ii w/integrated was broken at its silver brazing.No definitive root cause could be determined.It is possible that consistent use and reprocessing over the part¿s lifetime (16+ years) and excessive force(s) contributed to the complaint condition.During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h11: d11/concomitant products added to complaint.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.

• Brand Name: COLLAR POSITIONER FOR DUAL-OPENING IMPL F/6.0MM RODS
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9120466
• Report Number: 2939274-2019-60887
• Device Sequence Number: 2430772
• Product Code: HTC
• UDI-Device Identifier: 07611819847125
• UDI-Public: (01)07611819847125
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 388.151
• Device Lot Number: 1159723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 09/30/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 09/25/2019; 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - IMPACTION INSTRUMENTS: SPINE