MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 7 RT; FEMORAL TRIALS

Catalog Number	254500727
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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.H11 additional manufacturer narrative: 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 an unspecified surgical procedure, before starting the surgery, equipment is uncovered and it is evident that the hohmann separator was bent, in addition it is observed that the tibia impactor was split and the femoral component 7 right test was also split.For these novelties there was no discomfort of the specialist since although these references present quite remarkable novelties it was possible to use them, the surgery was completed successfully, without affectations of the patient and without alterations in the surgical times.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according for information received, please give a detailed explanation of the event.Broken locking mechanism of the handle.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed does not found signs of breakage at the attune ps fem trial sz 7 rt.However, the device has some scratches observed at the top of the surface.Additionally, under color marker was observed crack.Although no breakage condition was found, the reported allegation can be confirmed as the observed failure mode prevents the device working as intended in the same manner.The damage observed scratched in the provided evidence is consistent with a saw blade making contact with the device outside of its intended range/cutting section.Properly handling and attention to the approved use of the device diminishes the risk of failure.The potential cause broken is traced to repeated impaction forces during trialing in combination with the trial fitting very tightly posteriorly/anteriorly over the resected femur bone.This will cause tensile stress initiating at the bone contact surface in the middle of the trial between the condyles, resulting in material fatigue and ultimately cracking.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures as the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune ps fem trial sz 7 rt would have contributed to the complained device issue.Based on the investigation findings, 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 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 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.

• Brand Name: ATTUNE PS FEM TRIAL SZ 7 RT
• Common Device Name: FEMORAL 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: 23809890
• Report Number: 1818910-2025-21908
• Device Sequence Number: 15792804
• Product Code: HWT
• UDI-Device Identifier: 10603295133995
• UDI-Public: (01)10603295133995(10)MWMHQR140
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative,Distributor
• 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: 254500727
• Device Lot Number: MWMHQR140
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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