MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM HT SD X-DR SCR 5-PK; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number	95-6104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw fractured while pre-placing screws on the skull during a craniomaxillofacial procedure, and a new screw was immediately used as a replacement.The breakage was noted intra-operatively during setup for cranial fixation, and the reporter indicated the breakage may have caused skull damage or fallen parts during the surgery.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in china.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b5; h1; h2; h4; h6; h11.The reported event could not be confirmed due to product not returned.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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
It was reported that a screw fractured while pre-placing screws on the skull during a craniomaxillofacial procedure, and a new screw was immediately used as a replacement.The breakage was noted intra-operatively during setup for cranial fixation, and the reporter confirmed no foreign bodies were retained.The procedure was completed with a backup device.Attempts have been made, and no further information has been provided.

• Brand Name: 1.5X4MM HT SD X-DR SCR 5-PK
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• 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: 23957243
• Report Number: 0001032347-2026-00004
• Device Sequence Number: 12197344
• Product Code: GWO
• UDI-Device Identifier: 00841036056650
• UDI-Public: (01)00841036056650(10)66600155
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121624
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 95-6104
• Device Lot Number: 66600155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male