MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BROACH CORAIL AMT 13; HIP INSTRUMENTS : BROACHES

Catalog Number	L20413
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the warped metal on size 13 broach neck attachment.Modular neck trials getting stuck on broach.Very stiff and difficult to remove neck segment.Trialed different neck segments and all were difficult to remove.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > warped metal on size 13 broach neck attachment.Modular neck trials getting stuck on broach.Very stiff and difficult to remove neck segment.Tray a corail broaches and trials.Trialed different neck segments and all were difficult to remove.The product was not returned to j&j medtech orthopaedics.A photo was provided for review, however the photo only shows lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Functionality of the device cannot be assessed through photo evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the broach corail amt 13 would have not 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.

• Brand Name: BROACH CORAIL AMT 13
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22816529
• Report Number: 1818910-2025-14276
• Device Sequence Number: 13015316
• Product Code: HTQ
• UDI-Device Identifier: 10603295258155
• UDI-Public: (01)10603295258155(10)SO2019468
• 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: L20413
• Device Lot Number: SO2019468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2021
• 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