MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL BROACH SIZE 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	574999060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while removing the trial stem, the small metal attaching to the broach handle broke in the broach handle.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).G2 foreign: canada.H6 proposed component code: mechanical (g04) - rasp.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during removal of a size 6 trial stem, the small metal component that attaches to the broach handle fractured.During the event, the rasp remained in the patient; a slap hammer was threaded into the rasp and used to extract it.The patient had no consequences or impact.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5; d4; d9; g1; g3; h1; h2; h3; h4; h6.Visual examination of the returned product identified broach cutting teeth are dull and worn.Flat surface around the etch shows indentations and gouge damage from previous uses.No other damage is noted.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AVENIR CMPL BROACH SIZE 6
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22779456
• Report Number: 0001822565-2025-02881
• Device Sequence Number: 18597651
• Product Code: LZO
• UDI-Device Identifier: 00889024510166
• UDI-Public: (01)00889024510166(10)65331374
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182048
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 574999060
• Device Lot Number: 65331374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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