MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 5MM; PLATE, BONE

Catalog Number	95-6105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial procedure, five screws fractured intraoperatively.The procedure was completed using alternate screws.No fragments were retained, and there was no reported patient harm or contributing conditions.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): 01-7390 (054960), 15-1196 (365000).G2: foreign: the event occurred in china.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: d9, g3, h2, h3, h6 and h11.Complaint sample was evaluated, and the reported event was confirmed.An investigation was conducted on the returned screws.The screws all show signs of attempted use including marking and scratching on the screw surface.Further inspection shows that all five screws in the five pack have fractured.The complaint is confirmed.The screws were sent out for fracture analysis.The screws' fracture surfaces show sheared ductile dimples, indicating rotation crack propagation, suggesting torsional overload failure mode.Semi-quantitive eds elemental analysis found the material to be consistent with ti-6al-4v titanium alloy with carbon and oxygen contamination.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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 available at the time of this report.

• Brand Name: "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 5MM
• Common Device Name: PLATE, BONE
• 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: 21619392
• Report Number: 0001032347-2025-00131
• Device Sequence Number: 12895724
• Product Code: JEY
• UDI-Device Identifier: 00841036056667
• UDI-Public: (01)00841036056667(11)220719(10)J807210
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121589
• 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): 07/22/2025

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 Catalogue Number: 95-6105
• Device Lot Number: J807210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: H11.
• Patient Sex: Unknown