MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS TRL LNR N 54X40; HIP INSTRUMENT - ACETABULAR TRIAL LINER

Catalog Number	482254040
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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.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 screwdriver got stuck in trial liner.Upon removal, the trial liner broke.All pieces were removed and surgery time was not extended.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it was reported that screwdriver got stuck in trial liner.Upon removal, the trial liner broke.All pieces were removed and surgery time was not extended.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the rim around the screw has broken with the screw and rim still attached to the quickset taper hex scdr rigid.Screw and rim condition is likely resulting from exposure to unintended forces such as overtightening, an off-axis assembly or prying motions applied while device is assembled likely causing damage to the hex tip leading to the observed condition.A functional test was performed, and the quickset taper hex scdr rigid could not disassemble as intended.Considering the observed condition, it is suspected that the hex tip was damaged preventing the device to release.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 emsys trl lnr n 54x40 would have contributed to the complained issue.Based on the investigation findings, 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.H11 additional narrative: corrected: h3.

• Brand Name: EMSYS TRL LNR N 54X40
• Common Device Name: HIP INSTRUMENT - ACETABULAR TRIAL LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22872496
• Report Number: 1818910-2025-14661
• Device Sequence Number: 10424390
• Product Code: HWT
• UDI-Device Identifier: 10603295510741
• UDI-Public: (01)10603295510741(10)891894
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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

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: 482254040
• Device Lot Number: 891894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUICKSET TAPER HEX SCDR RIGID.
• Patient Age: 71 YR
• Patient Sex: Male