MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE REV SYSTM HEX ATTACHMNT; DRILL/DRIVER SHAFTS

Catalog Number	254600415
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was not possible to properly fix the trial augments in the trial tibiae.The threads of the trial appear to be cold welded.Two additional devices were found to be affected during analysis of returned devices.
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: h3, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the attune rev systm hex attachment had the tip slightly cross-threaded.The observed condition of the device appears to be a result from exposure to unintended forces, such as overtightening, off-axis assembly or prying motions applied during repeated assembly and disassembly with its mating device.A functional test was performed with the returned mating devices, and although the attune rev systm hex attachment exhibited slightly cross-threaded tips, this was successfully assembled without any issues.There were no signs of looseness or difficulties observed during assembly.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 attune rev systm hex attachment 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 review (dhr): quantity manufactured: (b)(4), date of manufacture: 12/30/2024, any anomalies or deviations identified in dhr: none, expiry date: n/a.

• Brand Name: ATTUNE REV SYSTM HEX ATTACHMNT
• Common Device Name: DRILL/DRIVER SHAFTS
• 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: 23349662
• Report Number: 1818910-2025-17913
• Device Sequence Number: 12705416
• Product Code: HWR
• UDI-Device Identifier: 10603295451280
• UDI-Public: (01)10603295451280(10)PU230229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,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: 254600415
• Device Lot Number: PU230229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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