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

Catalog Number	259807360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 instrument is fractured into two or more pieces at the joint-area.It was found in cssd.No adverse patient consequences, no fragment entered the surgical area, no surgical delay.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: h6 (health effect - impact code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "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 depuy synthes for evaluation.Visual inspection of the returned device found one portion of the hinge mechanism broken.Broken piece was returned for evaluation.Additionally, impaction marks could be observed on the proximal portion of the device.The nicks observed on the device can be attributed to a combination of heavy use and unintended impaction forces, most likely from bottom-up impactions applied to disengage the device, or in areas that are not intended to be impacted, such as the lever.These repeated unintended forces could have introduced stress to the device structure, potentially leading to the hinge breakage.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.A certificate of compliance was reviewed for the finished device ab4922142 lot number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the ant broach handle - r 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 depuy synthes 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: 36.2) date of manufacture: 09-jun-2019.3) any anomalies or deviations identified in dhr: no.4) expiry date: n/a.5) ifu reference: ifu-090200836 rev g.Device history review = > a certificate of compliance was reviewed for the finished device ab4922142 lot number, and no non-conformances nor manufacturing irregularities were identified.Corrected: h3.

• Brand Name: ANT BROACH HANDLE - R
• Common Device Name: HIP INSTRUMENTS : HANDLES
• 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: 23708654
• Report Number: 1818910-2025-21112
• Device Sequence Number: 21489959
• Product Code: HTQ
• UDI-Device Identifier: 10603295148302
• UDI-Public: (01)10603295148302(10)AB4922142
• 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,Followup,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: 259807360
• Device Lot Number: AB4922142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 12/22/2025; 02/04/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/19/2025; 12/23/2025; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2019
• 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