MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 ANTERIOR BROACH HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number	952212500F
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 broach handle was loose.All available information has been disclosed for reporting.No further information was provided.
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 that 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: d4 lot, d9, h4.Corrected: d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: it was reported that the broach handle was loose.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the corail2 anterior broach handle displays impaction marks and nicks on areas that are not intended to be impacted.A functional test was performed with a laboratory sample mating device, and the corail2 anterior broach handle was successfully assembled without any issues.However, it was noted that minimal force was required to open and close the lever and signs of looseness were observed on the lever as well.Nicks on the device can be attributed to a combination of heavy use and unintended impaction forces, likely from bottom-up impactions to disengage the device.Based on the observed condition, the potential cause of the loose condition can be attributed to an unintended use since impaction forces applied on these areas could result in affecting the mechanism.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 corail2 anterior broach handle would have 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.H11 additional narrative: added: g1 (manufacturing site name).Corrected: e4, h3.

• Brand Name: CORAIL2 ANTERIOR BROACH HANDLE
• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22323443
• Report Number: 1818910-2025-10469
• Device Sequence Number: 18389365
• Product Code: HTQ
• UDI-Device Identifier: 10603295230687
• UDI-Public: (01)10603295230687(10)SO2063555
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,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: 952212500F
• Device Lot Number: SO2063555
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/04/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 06/30/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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