MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL; TAP,BONE

Catalog Number 310.950

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 Description

Device report from synthes reports an event in canada as follows: it was reported that a 310.95 - mini quick coupling handle does not capture screwdriver shafts.Unknown if fragments were generated or if surgery was delayed due to the reported event.It is also unknown if procedure was successfully completed.Concomitant devices reported: unknown screwdriver shafts (part# unknown, lot# unknown, quantity# unknown).This complaint involves one (1) device.This report is for one (1) handle with mini quick coupling, stainless steel.This report is 1 of 1 for (b)(4).

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.Service & repair evaluation: the customer reported the mini quick coupling handle does not capture screwdriver shafts.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item passed synthes final inspection on 29-oct-2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was unconfirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history part: 310.950, lot: 9702982, manufacturing site: bettlach, release to warehouse date: 28.Dec.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
• Type of Device: TAP,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9167718
• MDR Text Key: 190383552
• Report Number: 2939274-2019-61297
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819019164
• UDI-Public: (01)07611819019164
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.950
• Device Lot Number: 9702982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 11/12/2019
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS