MAUDE Adverse Event Report: DePuy Ireland - 9616671 CORAIL; Hip Instruments : Broaches

Catalog Number	L20408
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
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 broach had been introduced into the femoral canal, and an osteotomy of the femur was required at a level below the tip of the broach, however, since the broach was inside the femur, its tip could not be seen from the outside, and when the surgeon used the saw, he ended up scoring the edge of the broach's tip.No patient or user harm and no significant delay were reported.

• Brand Name: CORAIL
• Common Device Name: Hip Instruments : Broaches
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50715639
• Report Number: 1818910-2026-15455
• Device Sequence Number: 10065941
• Product Code: HTQ
• UDI-Device Identifier: 10603295258100
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: L20408
• Device Lot Number: SO2002445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown