MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE REV FB TRIAL SIZE 7; TIBIAL TRAY TRIALS

Catalog Number	250610007
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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.
Event or Problem Description
It was reported that during a workshop, it was not possible to properly fix the the trial augments in the trial tibiae.It seems that something is wrong with the treads of the trial.They are somehow cold welded.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: during a workshop it was not possible to properly fix the trial augments in the trial tibiae.It seems that something is wrong with the treads of the trial.They are somehow cold welded.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis found that the attune rev fb trial size 7 was returned engaged with its mating device.Due to this condition it is reasonable to suspect that the threaded hole of the sample could be damaged.The assessment was performed and was able to replicate the reported unable to disassemble condition, the devices were unable to disengage after multiple attempts.Potential cause can be traced to unintended forces, such as overtightening, off-axis assembly or prying motions applied during repeated assembly and disassembly with its mating device.Properly handling and attention to the approved use of the device diminishes the risk of failure.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 fb trial size 7 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: 1) quantity manufactured: (b)(4) 2) date of manufacture: 11/24/2023 3) any anomalies or deviations identified in dhr: for top level assembly pn 250610007-12, 1 part was scrapped due to a big nick on front of part.4) expiry date: n/a 5) ifu reference: ifu-0902-00-836.H11 additional narrative: corrected: h3 and h4.

• Brand Name: ATTUNE REV FB TRIAL SIZE 7
• Common Device Name: TIBIAL TRAY TRIALS
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22922077
• Report Number: 1818910-2025-14684
• Device Sequence Number: 9116476
• Product Code: HWT
• UDI-Device Identifier: 10603295435907
• UDI-Public: (01)10603295435907(10)SO2064769
• 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,Followup

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: 250610007
• Device Lot Number: SO2064769
• 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): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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