MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB BROACH M-L 29MM; BROACHES

Catalog Number	251111101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
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
While broaching for the attune revision tibial sleeve, the 12x60 sheared off the 29mm tibial sleeve.Managed to fish the stem out with a long grasper so very little delay to the surgery and no harm to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "while broaching for the attune revision tibial sleeve the 12x60 sheared off the 29mm tibial sleeve.Managed to fish the stem out with a long grasper so very little delay to the surgery and no harm to the patient".The product was returned to depuy synthes for evaluation.Visual inspection revealed a broken fragment, from the mating component (attune rev p-f stem trl 12x60), assembled with the device (attune rev tib broach m-l 29mm) threaded surface.Device was forwarded to the materials team for a fracture analysis.A fractured attune stem trial and associated tibial broach was submitted for evaluation.All evaluations and examinations were performed nondestructively.The stem trial was fractured at the base of the threaded connection feature and the proximal portion was retained within the tibial broach.The proximal portion inside of the broach could not be extracted and was deep enough within the broach that direct examination of the fracture surface was not possible.No evidence of material or manufacturing defects was observed that could have contributed to fracture initiation and/or propagation to failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test revealed the broken fragment was unable to be retrieved from the device.Potential cause can be traced to a component failure traced by the damage observed.The overall complaint was confirmed as the observed condition of the attune rev tib broach m-l 29mm 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 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: a nc search was performed for the finished device pg275733 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.Corrected: h3.

• Brand Name: ATTUNE REV TIB BROACH M-L 29MM
• Common Device Name: 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: 23072974
• Report Number: 1818910-2025-16002
• Device Sequence Number: 14639891
• Product Code: HTQ
• UDI-Device Identifier: 10603295435754
• UDI-Public: (01)10603295435754(10)PG275733
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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

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: 251111101
• Device Lot Number: PG275733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2021
• 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