MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 6 RT; FEMORAL TRIALS

Catalog Number	254500706
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the femoral trial has damage around the lug hole due to overuse.In addition, the t-handle has a crack at the middle of the handle from overuse.No parts or pieces were broken off/ left behind but with further use could become more broken or unsafe if used in surgery.It did not happen in surgery.
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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the femoral trial has damage around the lug hole due to overuse.In addition, the t-handle has a crack at the middle of the handle from overuse.No parts or pieces were broken off/ left behind but with further use could become more broken or unsafe if used in surgery.It did not happen in surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the attune cr fem trial sz 6 rt had the lug hole worn out, additionally the metal bushing was missing from the device, likely due to the condition of the hole.The observed condition of the device can be attributed to a combination of heavy use and exposure to unintended forces during attempts of insertion or extraction of the trial while using the femoral trial gripper or when drilling using the patella femoral lug drill.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune cr fem trial sz 6 rt would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use 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 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.
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 reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received: 1.What was the exact allegation against the trial? was it worn, cracked, broken into pieces, bent, stripped, cross-threaded, or any device interaction? femur trial: the edge around the lug hole guide was wearing away due to overuse.T-handle: the middle of the handle was cracking.2.Was there a surgical delay? if yes, what is the duration of the delay? these issues did not cause delays or complications during surgery.3.Were there any adverse consequences that affected the patient because of the reported event? no adverse consequences.4.Did the handle break into two or more pieces? if no, please specify the alleged deficiency of the instruments.Were they bent, stripped, cross-threaded, etc.? yes, the handle was completely cracked through the middle.

• Brand Name: ATTUNE CR FEM TRIAL SZ 6 RT
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20317025
• Report Number: 1818910-2024-20283
• Device Sequence Number: 7679162
• Product Code: HWT
• UDI-Device Identifier: 10603295133780
• UDI-Public: (01)10603295133780(10)MVMJXS350
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 254500706
• Device Lot Number: MVMJXS350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 10/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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