MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANT BROACH HANDLE - L; HIP INSTRUMENTS : HANDLES

Catalog Number	259807350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: b3: event occurred on an unknown date in february 2025.
Event or Problem Description
It was reported that the item fractured into two or more pieces at the joint-area.Seen in the sterile processing department.There was no adverse patient consequence, no fragment entered the surgical area, and there was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary customer is complaining the instrument as it fractured into two or more pieces at the joint-area.Seen in cssd.No adverse patient consequences, no fragment entered the surgical area, no surgical delay.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.The device exhibits a condition consistent with normal use.No signs of breakage were observed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed using a sample broach and it revealed the ant broach handle - l was able to assemble and hold the broach correctly.The overall complaint was not confirmed as the observed condition of the ant broach handle - l would have not 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 1) quantity manufactured: (b)(4) 2) date of manufacture: 10/24/2018 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a 5) ifu-0902-00-836 receiving inspection records were reviewed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h3.

• Brand Name: ANT BROACH HANDLE - L
• Common Device Name: HIP INSTRUMENTS : HANDLES
• 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: 21604861
• Report Number: 1818910-2025-03968
• Device Sequence Number: 8895986
• Product Code: HTQ
• UDI-Device Identifier: 10603295148296
• UDI-Public: (01)10603295148296(10)AB4565066
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 259807350
• Device Lot Number: AB4565066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• 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: 03/28/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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