MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM TROCAR; GUIDE

Model Number	312.74
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
It was reported that on (b)(6) 2019, the one (1) trocar received was found bent.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) 1.6mm trocar.This is report 1 of 1 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: device history lot: part: 312.740.Lot: 3l50829.Manufacturing site: bettlach.Release to warehouse date: 21.Mar.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 1.6mm trocar (p/n 312.74 lot 3l50829) was received showing a bent shaft.The device was returned in unopened/original packing.No other issues were identified with the returned device.The complaint is confirmed.Device failure/defect identified? yes - the device failure/defect of a bent shaft was identified during the investigation.Dimensional inspection: feature: shaft diameter.Specification: 1.6 mm +0 /- 0.07 mm.Measured dimension: 1.54 mm.Result: conforming.Measurement device: caliper ca818.Document/specification review: relevant drawings, reflecting the manufactured and current revision, were reviewed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: a definitive assignable root cause for the post-manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.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.

• Brand Name: 1.6MM TROCAR
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9360442
• Report Number: 2939274-2019-62340
• Device Sequence Number: 11414653
• Product Code: FZX
• UDI-Device Identifier: 10886982187918
• UDI-Public: (01)10886982187918
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Model Number: 312.74
• Device Catalogue Number: 312.74
• Device Lot Number: 3L50829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1