MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PIN TRIAL SHELL 51 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701051
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cup handle could not be removed from cup trial.Threads seem to be cold welded together.It was unknown, if there was a surgical delay.
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that cup handle could not be removed from cup trial.Threads seem to be cold welded together.It was unknown, if there was a surgical delay.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it was returned in an assembled condition.After disassembly, it was observed that the threads at the apex hole were severely stripped.Potential cause can be attributed to unintended use error, this type of damage is likely due to repeated slightly off-axis assembly, overtightening, prying motion while assembling and heavy usage.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not conducted due to not being applicable to the complaint condition.A functional evaluation was revealed it was extremely difficult to disassemble the devices.The complaint condition was replicated however the allegation of jammed seized could not be confirmed.The overall complaint was confirmed as the observed condition of the pin trial shell 51 std profile would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use, and it has been determined that no corrective and/or preventative action is required.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 records evaluation (mre) was not performed.

• Brand Name: PIN TRIAL SHELL 51 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR 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: 20567916
• Report Number: 1818910-2024-22670
• Device Sequence Number: 7532215
• Product Code: HWT
• UDI-Device Identifier: 10603295097624
• UDI-Public: (01)10603295097624(10)SO2033077
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,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: 221701051
• Device Lot Number: SO2033077
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 12/19/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/07/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• 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 Age: 67 YR
• Patient Sex: Unknown