MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ5 5MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500651
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent a total knee prosthesis on (b)(6) 2025.During the procedure, an insert plate size 5 broke at the end of the tests.The device has been in contact with the patient.There was no consequence to patient or procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, " procedure: total knee prosthesis during the procedure.The device has been in contact with the patient.Insert plate size 5 broken at the end of the tests.No stop of the procedure.No technique change.No use of new device.No patient consequence." the product was not returned to medtech orthopaedics, however photos were provided for review.See attachment ¿(b)(4)¿.The photo investigation revealed that ' (b)(4), attune shim sz5 5mm was broken.The failure mode is consistent with using a device in a prying motion to disassemble the mating instruments after trialing resulting in material overload at the smallest cross-sectional area in middle of the shim.No material or manufacturing defects were observed that would have contributed to the fracture.A functional test was not performed since it was not applicable to the complaint condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune shim sz5 5mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be unintended use error caused or contributed to event 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 complaint condition.As part of 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: the device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE SHIM SZ5 5MM
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21751610
• Report Number: 1818910-2025-04949
• Device Sequence Number: 15512767
• Product Code: HWT
• UDI-Device Identifier: 10603295133438
• UDI-Public: (01)10603295133438(10)MVMFQG710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,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: 254500651
• Device Lot Number: MVMFQG710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/22/2026; 05/14/2026; 05/25/2026
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/03/2025; 04/30/2026; 05/15/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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