MAUDE Adverse Event Report: BIOMET MICROFIXATION BEUSE PLATE HOLDING FORCEPS; SURGICAL IMPLANT/TRIAL-IMPLANT/SIZER HOLDER, REUSABLE

Catalog Number	01-9095
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.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 a new forceps was found with a broken tip at the distributorship.Upon opening the new forceps, the tip was already broken prior to use.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The following sections were corrected: d9, h4.D9: product was not returned.H4: possible manufacturing dates: apr 8, 2025.Apr 11, 2025.The reported event was confirmed by review of pictures.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show the 01-9095 forceps outside of the original packaging.Further inspection shows that one of the tips has fractured on the forceps and is no longer attached.A photo was not provided of the fractured tip.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: BEUSE PLATE HOLDING FORCEPS
• Common Device Name: SURGICAL IMPLANT/TRIAL-IMPLANT/SIZER HOLDER, REUSABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23510834
• Report Number: 0001032347-2025-00434
• Device Sequence Number: 13250507
• Product Code: HRS
• UDI-Device Identifier: 00841036016791
• UDI-Public: (01)00841036016791(10)L24
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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: Other
• Device Catalogue Number: 01-9095
• Device Lot Number: L24
• Was Device Available for Evaluation?: No
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown