MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 16; HIP INSTRUMENTS : BROACHES

Catalog Number	L20416
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the size 16 broach damaged during trialling.The tip of broach was hit with a mallet accidentally, deforming the tip of broach, resulting in a trial neck not fitting.There was a 3-4 minutes of surgical delay.A new tray of broaches was opened, the damages broach removed and replaced with another of the same size.The procedure was successfully completed.There was no patient consequence.
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.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.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).Investigation summary: according to the information received, ¿size 16 broach damaged during trailing.Tip of broach was hit with a mallet accidentally, deforming the tip of broach, resulting in a trial neck not fitting." the product was not returned to medtech orthopaedics, however photos were provided for review.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 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 number 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: BROACH CORAIL AMT 16
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22236204
• Report Number: 1818910-2025-09913
• Device Sequence Number: 20837923
• Product Code: HTQ
• UDI-Device Identifier: 10603295258186
• UDI-Public: (01)10603295258186
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: L20416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/22/2025
• 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: Male