MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 15; HIP INSTRUMENTS : BROACHES

Catalog Number	L20415
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a tha surgery with corail performed with the product in question.In the surgery during the trial, the corail amt broach size 15 and the corail amt neck segment kla 125 degrees did not fit together properly, which extended the procedure time by about 15 minutes.After several trials, it was confirmed that the products fit together, but they could not be attached or detached smoothly.The surgeon checked five necks of the products in question, and found that, like the issue in question, they could be fitted together but could not be removed smoothly.In addition, since the issue was not confirmed with other size broaches and neck segments, there may be a problem with the corail amt broach size 15.The surgery was completed successfully with 15 minutes of surgical delay.No further information is available.
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 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 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 :d9.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 on (b)(6) 2025, the patient underwent a tha surgery with corail performed with the product in question.In the surgery during the trial, the corail amt broach size 15 (l20415) and the corail amt neck segment kla 125 degrees (l94004) did not fit together properly, which extended the procedure time by about 15 minutes.After several trials, it was confirmed that the products fit together, but they could not be attached or detached smoothly.The surgeon checked the following five necks of the products in question, and found that, like the issue in question, they could be fitted together but could not be removed smoothly.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis found that the broach corail amt 15 was returned disengaged, nothing indicative of a device nonconformance was identified.The sample only exhibits signs of repetitive use for a long period of time.Even though a proper assessment was not performed due to the mating component was not returned.For reference a functional evaluation was conducted using a lab sample mating device and the broach does not shows difficulties while assembling or disassembling.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the broach corail amt 15 would have not 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 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: corrected: h3.

• Brand Name: BROACH CORAIL AMT 15
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22396500
• Report Number: 1818910-2025-11280
• Device Sequence Number: 20033629
• Product Code: HTQ
• UDI-Device Identifier: 10603295258179
• UDI-Public: (01)10603295258179(10)SO2042107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: L20415
• Device Lot Number: SO2042107
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 09/08/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/15/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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