MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET FLEX CLAMP BROACH HNDL; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the while impacting the broach with the broach handle attached the impactor plate broke off the end.There were two (2) broach handles in the set, so the case was proceeded with the one handle to complete the case without delay or impact on the patient.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4 (udi #), g3, g6, h2, h3, h6, h11.Corrected: d4 (expiration date), no expiration date is noted.Complaint can be confirmed through the returned product analysis.The strike plate is fractured from the handle body within the welded region.Visual examination of the returned product identified the t-handle component was not returned with the device.The strike plate is fractured from the handle body within the welded region.There are indentation marks on both sides of the strike plate.There are indentations and scratches present along the handle body and broach connection end.No other damage was noted during visual evaluation.This device has an approximate field age of 8.5 years.Optical images of the device fracture surfaces exhibit river lines and hinge artifacts, suggesting that the device possibly fractured due to bending overload.Review of the device history record 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OFFSET FLEX CLAMP BROACH HNDL
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23379445
• Report Number: 0001825034-2025-03331
• Device Sequence Number: 15753682
• Product Code: LXH
• UDI-Device Identifier: 00880304522749
• UDI-Public: (01)00880304522749(11)170321(10)550480
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Model Number: N/A
• Device Catalogue Number: 31-555408
• Device Lot Number: 550480
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2017
• 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