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

Model Number	310.95
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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) 2021, during cleaning, the technician noticed that the screw shafts would not connect or stay in when inserted to both handles with mini quick coupling, stainless steel.There was no patient involvement.This report involves one (1) handle with mini quick coupling, stainless steel.This is report 1 of 2 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, h6: the subject 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
This is report 1 of 3 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, h6: part: 310.950, lot: 2605240, manufacturing site: bettlach, release to warehouse date: may 19, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: hndl mini qc, stainless steel was returned and received at us customer quality (cq).Upon visual inspection, no issues were identified with the device.Service and repair evaluation: the customer reported the screw shafts will not connect or stay in when inserted to both handles with mini quick coupling, stainless steel.The repair technician reported device will not couple with bit.Coupler damaged is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Functional test: the functional test was performed at service and repair, and during the functional test it was determined that the coupler on the device was damaged, which could have caused the complaint condition.Dimensional inspection: complaint relevant dimensions cannot be taken because of the geometry/design of the device.Document/ specification review: -handpiece (current and manufactured) no design issues or discrepancies were identified.Investigation conclusion the complaint condition was confirmed.No definitive root-cause can be determined based on the provided information.The potential cause could be due to unintended forces applied to the device.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: HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
• Common Device Name: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11796985
• Report Number: 2939274-2021-02269
• Device Sequence Number: 17308929
• Product Code: HWX
• UDI-Device Identifier: 10886982187147
• UDI-Public: (01)10886982187147
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2021

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: 310.95
• Device Catalogue Number: 310.95
• Device Lot Number: 2605240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 06/09/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/11/2021
• 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: HNDL MINI QC, STAINLESS STEEL; UNK - SCREWS: TRAUMA; HNDL MINI QC, STAINLESS STEEL; UNK - SCREWS: TRAUMA