MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-HANDLE WITH QUICK COUPLING; TAP, BONE

Model Number	311.44
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant device is expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a lead spd technician gave a peel of pack defective instruments.Four t8 star-drive, one t-handle with quick connect, and one 2.0/2.4 depth gauge.Three of the t8 star-drive are twisted, on e star-drive and the t-handle will not come apart, and the depth gauge is broken.It was unknown how the issue was discovered.It was unknown of there was patient involvement.This complaint involves six (6) devices.This report is for one (1) t-handle with quick coupling.This report is 1 of 6 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.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.The device received is not a depuy synthes device.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: T-HANDLE WITH QUICK COUPLING
• 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: 12121658
• Report Number: 2939274-2021-03413
• Device Sequence Number: 17038455
• Product Code: HWX
• UDI-Device Identifier: 10886982187413
• UDI-Public: (01)10886982187413
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 311.44
• Device Catalogue Number: 311.44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM; DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SDDRIVE SCREWDRIVER SHAFT T8 105MM