MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT +4 40ID 58OD; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221840458
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The instrument was reported for an unknown reason.Did not happen in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "the instrument was reported for an unknown reason.Did not happen in surgery" and "the numbers provided were the only numbers on the instrument.Our team sent back the instrument with the broken pieces together.The instrument was a 58 40 +4/10 liner trial.I hope this helps".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed signs of heavy usage and the outer surface of the pin trl lnr neut +4 40id 58od scratched.Additionally, the threaded insert of device was found disassembled and the snap ring was not returned for evaluation.Scratches are consistent with other tools and hard edges coming in contact with the device.However, takin into account the age and aspect of the device, the observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.The observed conditions of the threaded insert and ring were consistent with a component failure that was caused by over-tightening the threaded insert during used, and subsequently and unintentionally disassembling the snap ring from it.Properly handling and attention to the approved use of the device diminishes the risk of failure.Without concrete evidence nor further evidence, a potential cause for the missing component (ring) remains as unknown.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.A device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code pg0408 provided is not a valid finished goods lot number.The overall complaint was confirmed as the observed condition of the pin trl lnr neut +4 40id 58od would have contributed to the complained device 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code pg0408 provided is not a valid finished goods lot number.Corrected: h3.

• Brand Name: PIN TRL LNR NEUT +4 40ID 58OD
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21927634
• Report Number: 1818910-2025-06631
• Device Sequence Number: 15724834
• Product Code: HWT
• UDI-Device Identifier: 10603295101536
• UDI-Public: (01)10603295101536(10)PG0408
• 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,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: 221840458
• Device Lot Number: PG0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2008
• 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