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	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: france.H6: suggested 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 supplemental mdr will be submitted.
Event or Problem Description
It was reported that the tip of the size 6 rasp broke cleanly during surgery.The fractured piece was extracted using the mass from the ancillary device.There were no health consequences for the patient; the event only resulted in a delay of the procedure of 15 (fifteen) minutes.No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified the post of the broach is fractured at its base.The broach connection end has nicks and wear.The cutting teeth have nicks and dulling.No other damage was noted during visual evaluation.This device has an approximate field age of 4.5 years.Measurements are within limits.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor trends.
Event or Problem Description
Due diligence is complete as multiple attempts were made; however, no further information is available.

• 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: 23463722
• Report Number: 0001822565-2025-03971
• Device Sequence Number: 10408096
• Product Code: LZO
• UDI-Device Identifier: 00889024510166
• UDI-Public: (01)00889024510166(11)210304(10)64996699
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 64996699
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Male