MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM HT SD X-DR SCR EA; FASTENER, PLATE, CRANIOPLASTY

Catalog Number	91-6104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4).D10 ¿ medical products item # 91-6104, lot # j67068443: 1.5x4mm ht sd x-dr scr ea.G2: foreign source: brazil.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.
Event or Problem Description
It is reported that during a cranial procedure, screws fractured during the procedure after implantation.Patient will be monitored for any problems that might be concerned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: a2, b5, d10, e1, h2, h3, h4, h6 and h11.D10 - concomitant medical products: item #: 01-7104 item name: 1.5 5 hole xlong y lot #: j7698662 item #: 01-7136 item name: 1.5 2x3 hole rectangle lot #: 241750 item #: 01-8664 item name: plate rgd 1.5/0.6 4 hole lot #: 722460 item #: 91-6104 item name: 1.5x4mm ht sd x-dr scr ea lot #: j66803168 qty: 7 item #: 01-9123 item name: depth gage 1.5/2.0 45mm lot #: int019123.Reported event was unable to be confirmed due to limited information received from the customer.Product was not returned as it was retained by the patient.Dhr was reviewed and no discrepancies related 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 the patient underwent a craniotomy procedure.During the procedure, two self-drilling screws fractured after being implanted in the cranial region.The fractured devices were retained.Due to the event, there was a small delay in the procedure.Patient expired five days post procedure.The patient had cancer and underwent a craniotomy to remove a tumor.The patient suffered a hematoma that was not related to the implanted product and the surgeon stated this is the reason the patient expired.

• Brand Name: 1.5X4MM HT SD X-DR SCR EA
• Common Device Name: FASTENER, PLATE, CRANIOPLASTY
• 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: 22106225
• Report Number: 0001032347-2025-00221
• Device Sequence Number: 20886751
• Product Code: HBW
• UDI-Device Identifier: 00841036053734
• UDI-Public: (01)00841036053734(10)J67068443
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K953385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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
• Device Catalogue Number: 91-6104
• Device Lot Number: J67068443
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male