BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0X7MM BONE REDUCTION BLADE

    MDR report key: 11086845 · Received December 29, 2020

    Report

    Report Number
    0001032347-2020-00628
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 3, 2020
    Report Date
    September 23, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWI
    UDI-DI
    00841036145491
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1, D2, D4, H4 THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H10 QUANTITY OF ONE 2.0X7MM BONE REDUCTION BLADE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION IDENTIFIED THE TIP TO BE FRACTURED. THE PART AND LOT INFORMATION WERE VERIFIED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW TIP BROKE DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A ZYGOMATIC FRACTURE. THE SCREW TIP REMAINED IN THE BODY WITHOUT REDUCTION. THE BONE WAS SCRAPED AND THE SCREW TIP FRAGMENT WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550724 2.0X7MM BONE REDUCTION BLADE ORTHOPAEDIC KNIFE HWI BIOMET MICROFIXATION N/A 933340 00841036145491

    Patients

    Seq Age Sex Outcome Treatment
    1