MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB PREP PLATE SZ2; TIBIAL BASE PLATES

Catalog Number	250620002
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an issue was identified during instrument inspection.There were fragments/burrs inside holes on the instrument.No further information was provided.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary instruments enter [redacted] qa process before acceptance and the following issue.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) ha-014556 fw user report on 2025002004501003 mhra ref 34629847-aicxml.The photo investigation revealed signs of burr on the insertion holes of the attune rev tib prep plate sz2.However, no signs of breakage were not found.The observed condition may be due to multiple attempts at assembly and disassembly of the low-profile tibial pin; however, a definite root cause cannot be established with the photos provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device product description: attune rev tib prep plate sz2 product code: 250620002 lot number: pc5645379 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the attune rev tib prep plate sz2 would have contributed to the complained device 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 manufacturing record evaluation was performed for the finished device product description: attune rev tib prep plate sz2 product code: 250620002 lot number: pc5645379 and no non-conformances or manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device product description: attune rev tib prep plate sz2 product code: 250620002 lot number: pc5645379 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: ATTUNE REV TIB PREP PLATE SZ2
• Common Device Name: TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21534868
• Report Number: 1818910-2025-03512
• Device Sequence Number: 8050267
• Product Code: HWT
• UDI-Device Identifier: 10603295435952
• UDI-Public: (01)10603295435952(10)PC5645379
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• 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: 250620002
• Device Lot Number: PC5645379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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