MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 11; HIP INSTRUMENTS : BROACHES

Catalog Number	L20411
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the instruments were noticed to be are broken upon inspection.The top ball does not go in to slide on the trial.The broach does not lock in on the handle.The device does not slide into the broach.There was a crack on the tightening wheel.Surgical delay was unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = according to the information received, ¿it was reported that the instruments were noticed to be are broken upon inspection.The top ball does not go in to slide on the trial.The broach does not lock in on the handle.The device does not slide into the broach.There was a crack on the tightening wheel.Surgical delay was unknown.¿ the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device observed sign of normal use on the device.A functional test performed with a mating broach handle (952210500f) revealed that the broach was able to be assemble as intended.Complaint was not confirmed.The overall complaint was unconfirmed as the observed condition of the broach corail amt 11 would not contribute 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 depuy synthes 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.
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.

• Brand Name: BROACH CORAIL AMT 11
• Common Device Name: HIP INSTRUMENTS : BROACHES
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18334721
• Report Number: 1818910-2023-25380
• Device Sequence Number: 15131563
• Product Code: HTQ
• UDI-Device Identifier: 10603295258131
• UDI-Public: 10603295258131
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/15/2023

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: L20411
• Device Lot Number: SO2041004
• 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: 12/09/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/09/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/08/2024; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2018
• 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