MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STRAIGHT BROACH HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number	952210500F
Medical Device Problem Code	Structural Problem (2506)
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
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 user was going through some of their older instrument sets today and found two corail straight broach handles that had a failed locking mechanism and need to be replaced.This event did not happen in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that user was going through some of their older instrument sets today and found 2 corail straight broach handles that had failed locking mechanism and need to be replaced.This event did not happen in surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the locking mechanism of the corail2 straight broach handle was loose.The device displays wear consistent with the time of service and use.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed using a lab sample mating device and corail2 straight broach handle was found to be loose from the locking mechanism / lever.As a result, the device was difficult to lock with its mating component.The overall complaint was confirmed as the observed condition of the corail2 straight broach handle 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 required.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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (j1109) provided is not a valid finished goods lot#.H11 additional narrative: added: d9, d10.Corrected: h3.

• Brand Name: CORAIL2 STRAIGHT BROACH HANDLE
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22107844
• Report Number: 1818910-2025-08696
• Device Sequence Number: 12581831
• Product Code: HTQ
• UDI-Device Identifier: 10603295230656
• UDI-Public: (01)10603295230656(10)J1109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: 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: 952210500F
• Device Lot Number: J1109
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 STRAIGHT BROACH HANDLE; CORAIL2 STRAIGHT BROACH HANDLE
• Patient Sex: Unknown