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	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the broach handle has a part broken off at the instrument´s joint-area.No surgical delay, no adverse patient consequences reported.
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.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 customer is complaining the instrument as a part has broken off at the instrument´s joint-area.No surgical delay, no adverse patient consequences reported.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device confirmed a breakage condition on the hinge.They were also observed impaction nicks marks on areas which are not intended to be impacted specially on the lever and handle.Fragment was not returned for evaluation.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.These repeated unintended forces could have introduced stress to the device structure, potentially leading to the hinge breakage.A functional test was performed with a laboratory sample broach (257000150) and the broach handle didn't show difficulties for assembling and staying well fitted.A dimensional inspection was not performed since it was not applicable to the complaint condition.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, the potential cause is traced to unintended use error, 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 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: 38 2) date of manufacture: 21 jan 2019 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a 5) ifu reference: 090200836 rev g device history review a manufacturing record evaluation was performed for the finished device product description: ant broach handle - r product code: 259807360 lot number: ab4656846 and no non-conformances or manufacturing irregularities were identified.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20614984
• Report Number: 1818910-2024-23117
• Device Sequence Number: 8793000
• Product Code: HTQ
• UDI-Device Identifier: 10603295148302
• UDI-Public: (01)10603295148302(10)AB4656846
• 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

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: AB4656846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 01/22/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/18/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• 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