BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM X-LOCK STD BLADE

    MDR report key: 3211736 · Received July 8, 2013

    Report

    Report Number
    0001825034-2013-02523
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RADIAL HEAD REPLACEMENT PROCEDURE ON (B)(6) 2013. DURING TIGHTENING OF THE SCREWS, THE TIP OF THE SCREWDRIVER FRACTURED IN THE PATIENT. NO FOREIGN BODY WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309478 2.4MM X-LOCK STD BLADE BLADE, SAW, GENERAL AND PLASTIC SURGERY GFA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R