MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT TRL41MM; ATTUNE INSTRUMENTS : PATELLA TRIALS

Catalog Number	254501029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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.
Event or Problem Description
It was reported that during routine inspections of attune instrument consignment trays at the hospital, eight attune instruments were found to be damaged.Five shims were found to be cracked, with cracks extending from the metal drill guides to the outer or inner edge of each shim.Also, an attune spacer block was found to be missing two of its four bal seal springs and a patella trial was found to be missing one of its three lugs, finally, a cr femur trial has a transverse cut line across its distal condyles, likely caused by a sagittal saw.It is unknown when, where, or how the instruments were damaged.
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 that 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 recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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: e3.Corrected: e2.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: according to the information provided: "it was reported that during routine inspections of attune instrument consignment trays at hospital, eight attune instruments were found to be damaged.Five shims were found to be cracked, with cracks extending from the metal drill guides to the outer or inner edge of each shim.Also, an attune spacer block was found to be missing two of its four bal seal springs and a patella trial was found to be missing one of its three lugs, finally, a cr femur trial has a transverse cut line across its distal condyles, likely caused by a sagittal saw.It is unknown when, where, or how the instruments were damaged.Replacement instruments are needed to complete the instrument trays".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found one of the base prongs broken.Device had signs of usage and no other anomaly was identified on its surface.Broken piece was not returned for evaluation.Breakage observed can be consistent with exposure to unintended forces like usage of excessive force in a prying motion while trialing.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.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune medial dome pat trl41mm 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 depuy synthes 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11.Additional narrative: corrected: h3.

• Brand Name: ATTUNE MEDIAL DOME PAT TRL41MM
• Common Device Name: ATTUNE INSTRUMENTS : PATELLA TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23851378
• Report Number: 1818910-2025-22270
• Device Sequence Number: 9571818
• Product Code: HWT
• UDI-Device Identifier: 10603295136064
• UDI-Public: (01)10603295136064(10)MVMHHC620
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 254501029
• Device Lot Number: MVMHHC620
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/05/2026; 01/19/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/06/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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