BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE DRIVE SILVER

    MDR report key: 21633028 · Received March 18, 2025

    Report

    Report Number
    0001032347-2025-00134
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWR
    UDI-DI
    00851599007655
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G3, G6, H2, H3, H4, H6, H11. A VISUAL INSPECTION WAS CONDUCTED ON THE QTY ONE 201.047.15 BLADE LOT NUMBER 1123101 AND QTY ONE 201.047.15 LOT NUMBER 1122416. BOTH BLADES SHOW SIGNS OF MULTIPLE USES INCLUDING HEAVY MARKING AND SCRATCHING ON THE BLADE SURFACES. FURTHER INSPECTION SHOWS THAT BOTH BLADES HAVE TWISTED/ BENT. THE COMPLAINT FOR BOTH BLADES IS CONFIRMED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE BLADES TO TWIST/ BEND. REVIEW OF THE DHR'S IDENTIFIED NO DEVIATIONS OR ANOMALIES. SUPPLIER DHR REVIEWS WERE NOT PERFORMED AS PRODUCTS HAVE APPROXIMATE FIELD AGES OF 1 AND 2 YEARS, WITH AN UNKNOWN NUMBER OF USES. VISUAL INSPECTION SHOWS SIGNS OF MULTIPLE USES INCLUDED MARKING/ SCRATCHING ON THE PRODUCT SURFACE AND THERE IS NO INDICATION THAT A MANUFACTURING DEFICIENCY OCCURRED. HARM SEVERITY 1/2 NON-REPORTABLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON PRODUCT RETURN. THE DEVICE EVALUATION FOUND THAT THE DEVICE WAS NOT FRACTURED, BUT RATHER BENT/TWISTED. THIS IS NOT A REPORTABLE MALFUNCTION AND BASED ON AVAILABLE INFORMATION, THE EVENT DID NOT CONTRIBUTE TO PATIENT INJURY. THEREFORE, THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLADE FRACTURED WITH THE TIP BEING FRACTURED OFF. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212483 T15 HEXALOBE DRIVE SILVER DRIVER, PROSTHESIS HWR BIOMET MICROFIXATION 1122416 00851599007655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown