MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SIG HP REV TORQ LMT SCRWDRVR; KNEE INSTRUMENT : TORQUE DEVICES

Catalog Number	201103080
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it exhibits a condition consistent with normal use.The device was returned in an assembled condition with sig hp rev torq lmt scrwdrvr.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed and it revealed it was not possible to disassemble the returned devices.The complaint condition was replicated.The potential cause for the observed failure mode can be attributed to galling or damage to the locking mechanism, however, since it was not possible to disassemble the devices, a potential cause was not established.The overall complaint was confirmed as the observed condition of the sig hp rev torq lmt scrwdrvr would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to not established, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.
Event or Problem Description
It was reported that the hex screw driver and bit were stuck together.It was noticed when resetting the tray.

• Brand Name: SIG HP REV TORQ LMT SCRWDRVR
• Common Device Name: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21766489
• Report Number: 1818910-2025-05083
• Device Sequence Number: 12964707
• Product Code: HXX
• UDI-Device Identifier: 10603295436379
• UDI-Public: (01)10603295436379(10)KM966456
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 201103080
• Device Lot Number: KM966456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown