MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 4 RT; FEMORAL TRIALS

Catalog Number	254500704
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2024 that trial was cracked.
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the attune cr fem trial sz 4 rt was broken in two pieces.The fracture surface is consistent with overload due to a combination of heavy impaction and the trial fitting too tight over the posterior/anterior aspect of the resected femur bone forcing the curved features of the femoral trial to open.The combination of heavy impaction and possible discrepancies in the resection depth between the femur and the trial suggest unintended user error.Furthermore, per the attune surgical technique it is cautioned when extracting the trial, rocking the trial medio-laterally may cause condylar fracture.Such rocking should be avoided.A functional test was not performed due to the post-manufacturing damage.A dimensional inspection was not performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 4 rt would have contributed to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended user error, 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 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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM TRIAL SZ 4 RT
• Common Device Name: FEMORAL 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: 20646318
• Report Number: 1818910-2024-23377
• Device Sequence Number: 7464102
• Product Code: HWT
• UDI-Device Identifier: 10603295133766
• UDI-Public: (01)10603295133766(10)MVMHJL400
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 254500704
• Device Lot Number: MVMHJL400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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: Female