MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET FLEX CLAMPING; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ canada.The 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 the rasp handle broke.There was no known impact or consequences to the patient.It was reported that no further information is available.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6 visual examination of the provided picture identified signs of use (scratches).The device has fractured at the weld location.No device returned, no further analysis can be made.Medical records were not provided.A definitive root cause cannot be determined.This complaint can be confirmed via the provided picture.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 for trends.
Event or Problem Description
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 b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified the strike plate is fractured from the handle body at the weld that assembles the strike plate to the handle body.The broach t-handle component was not returned with the device for evaluation.There are indentation marks on both sides of the strike plate and the handle body.Nicks and scratches are present along the handle body as well.No other damage was noted during visual evaluation.This device has an approximate field age of 4 years.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.A definitive root cause cannot be determined.This complaint can be confirmed via the product returned.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 for trends.

• Brand Name: OFFSET FLEX CLAMPING
• Common Device Name: INSTRUMENT, HIP
• 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: 20773164
• Report Number: 0001825034-2024-02771
• Device Sequence Number: 4499223
• Product Code: LXH
• UDI-Device Identifier: 00880304522749
• UDI-Public: (01)00880304522749(11)201218(10)422340
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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 Model Number: N/A
• Device Catalogue Number: 31-555408
• Device Lot Number: 422340
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 03/12/2025; 09/08/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 03/14/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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