MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM DISMBLY TRQ SHFT 85MM; TORQUE DEVICES

Catalog Number	297500735
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 85mm torque shaft and pushrod were cold welded (inseparable).The pushrod tip was bent.The body collet expansion tips sheared off(fragments were disposed of by facility).
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: it was reported that 85mm torque shaft and pushrod were cold welded (inseparable).Pushrod tip bent.Body collet expansion tips sheared off (fragments were disposed of by facility).The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the reclaim dismbly trq shft 85mm is jammed with the reclaim disassembly pushrod.The observed condition of the device is consistent with a random component failure, potentially resulting from heavy use or improper handling.Specifically, an off-axis assembly of the reclaim disassembly pushrod that may have been applied unintended forces on the push rod, contributing to the condition.A functional test was performed, and it was observed that the reclaim dismbly trq shft 85mm was jammed.Therefore, assembly and disassembly of the device is not possible.It is suspected that an off-axis assembly is preventing the rod from disassemble.Consequently, the reported allegation can be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim dismbly trq shft 85mm would have contributed to the complained issue.Based on the investigation findings, 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.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (j1111) provided is not a valid finished goods lot number.

• Brand Name: RECLAIM DISMBLY TRQ SHFT 85MM
• Common Device Name: TORQUE DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21056462
• Report Number: 1818910-2025-00026
• Device Sequence Number: 8783140
• Product Code: LXH
• UDI-Device Identifier: 10603295156116
• UDI-Public: (01)10603295156116(10)J1111
• 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,Followup
• Report Date (Section B): 01/02/2025

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: 297500735
• Device Lot Number: J1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2011
• 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