MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 36MM PINN AB IN TR 54; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221887354
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that during the surgery, the test insert was broken.The specialist was annoyed that there were no more test inserts of the same characteristics and measurements inside the equipment.There was no way to give a solution, and then it was resolved using this same test implant without the part of the screw that was broken, and had to remove it with a kelly clip.The surgery was successfully completed, but with an affectation of (15) fifteen minutes in the surgical times by the maneuver that had to be performed with the clamp.There were no affectations to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "during the surgery the test insert of 36*54 ref was broken, for this novelty the specialist was annoyed that there were no more test inserts of the same characteristics and measured inside the equipment, there is no way to give a solution and then it is resolved using this same test implant without the part of the screw that was broken and touched to remove it with a kelly clip; the surgery was successfully completed, but with an affectation of (15) fifteen minutes in the surgical times by the maneuver that had to be performed with the clamp, there were no affectations to the patient and at the end it is left report in the case report, in the one force and this medium in order to report what happened, also the aforementioned test insert is marked with red tape and left inside the devices for easy identification and change when the equipment returns to j&j facilities.(photographic records are annexed)." the product was not returned to medtech orthopaedics, however photos were provided for review.See attachment ¿source file -(b)(4).The photo investigation revealed that '221887354, 36mm pinn ab in tr 54' had broken.The observed condition of the device was consistent with a component failure that was caused by over-tightening the threaded insert during used and intentionally disassembling the snap ring from it for surgical preference or cleaning.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 36mm pinn ab in tr 54 would contribute to the complained device issue.Based on the investigation findings, unintended use error caused or contributed to event 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 complaint condition.As part of 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 device lot is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: 36MM PINN AB IN TR 54
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21607626
• Report Number: 1818910-2025-03982
• Device Sequence Number: 8896081
• Product Code: HWT
• UDI-Device Identifier: 10603295101925
• UDI-Public: (01)10603295101925
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,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: 221887354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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