MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TROCAR WITH HANDLE FOR USE WITH 03.120.014; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, 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
It was reported that on (b)(6) 2020, the trocar handle is not holding trocars like it should be.There was no surgical delay.Procedure was successfully completed.No patient consequences reported.This report is for one (1) trocar with handle for use with 03.120.014.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.H3, h4, h6: part: 03.120.015.Lot: 8102227.Manufacturing site: hägendorf.Release to warehouse date: january 08, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the trocar with handle for use with 03.120.014 was received at us customer quality (cq).Upon visual inspection it was noticed there were no defects on the device itself.Functional test: functional test was not performed as the mating device was not returned.The complaint replication is unable to be performed with the returned devices.Trocar od = conforming.Document/ specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: the complaint cannot be confirmed as the mating device(s) were not received.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: TROCAR WITH HANDLE FOR USE WITH 03.120.014
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10567934
• Report Number: 2939274-2020-04246
• Device Sequence Number: 2618801
• Product Code: FZX
• UDI-Device Identifier: 10886982074133
• UDI-Public: (01)10886982074133
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 03.120.015
• Device Catalogue Number: 03.120.015
• Device Lot Number: 8102227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1