MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 9 RT; FEMORAL TRIALS

Catalog Number	254500729
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 patient underwent total knee arthroplasty (tka) on (b)(6) 2025.After the procedure, the trial femur size 9 was identified by cssd as being damaged (saw marks and diathermy burns and was deemed not usable.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, after todays tkr the consigned item mvmcrr170 lot d254500729 trial femur size 9, was identified by cssd as being damaged (saw marks and diathermy burns) and was deemed damaged and not usable.It has been decontaminated, separated and labeled as damaged.The product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that ' 254500729, attune ps fem trial sz 9 rt had scratched and foreign substances on it."this type of damage is consistent with the device coming in contact with the saw blade while trialing, care should be taken to avoid saw blade excursion into the femoral trials or implants." the observed condition is likely due to improper cleaning/sterilization.The photo also revealed that the device has cracked on it.The potential cause 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." since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune ps fem trial sz 9 rt would contribute to the complained device issue.Based on the investigation findings, unintended user error and end of life 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 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: added: g1 (manufacturing site name).The expiration date (7/28/2025) in the previous medwatch was reported in error.The device involved was an instrument and does not have an expiration date.

• Brand Name: ATTUNE PS FEM TRIAL SZ 9 RT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22184187
• Report Number: 1818910-2025-09500
• Device Sequence Number: 8356644
• Product Code: HWT
• UDI-Device Identifier: 10603295134015
• UDI-Public: (01)10603295134015(10)MVMCRR170
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Expiration Date: 07/28/2025
• Device Catalogue Number: 254500729
• Device Lot Number: MVMCRR170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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