BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6254432 · Received January 16, 2017

    Report

    Report Number
    0001032347-2017-00045
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Date of Event
    December 21, 2016
    Report Date
    December 7, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE AND 510(K) NUMBER. THE FOLLOWING SECTIONS WERE CORRECTED: DEVICE PRODUCT CODE: JEY CORRECTED TO HRS. PMA/510(K) NUMBER: K121589 CORRECTED TO K142823.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 0001032347-2017-00044.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITIES WERE CONFIRMED IN THE EVALUATION. THE DRIVERS WERE VISUALLY EVALUATED AND THEY SHOW SIGNS OF NORMAL USE. THE DRIVERS WERE TESTED WITH A BLADE, A SCREW, AND POPLAR. THE BLADE COULD BE SUCCESSFULLY INSERTED INTO THE DRIVERS. THE SCREW COULD BE INSERTED INTO THE POPLAR, BUT THE DRIVERS BOTH HAD CHOPPY MOVEMENT. THEY STICK AT MULTIPLE POINTS THROUGHOUT THE ROTATION. THE DRIVERS WERE DISASSEMBLED AND THE INTERNAL COMPONENTS WERE EVALUATED. IT WAS NOTICED THAT THE HORIZONTAL INTERNAL SHAFT HAD A SLIGHT ECCENTRIC MOTION WHICH WOULD EXPLAIN THE STICKING AT ONE POINT IN THE ROTATION. THE BENT SHAFT LIKELY OCCURRED FROM EXCESSIVE FORCE APPLIED TO THE DRIVER, CAUSING DEFLECTION IN THE SHAFT. THIS WOULD OCCUR IF THE SCREW WAS FULLY SEATED AND FORCE WAS CONTINUED TO BE APPLIED. THE GEARS WOULD TEND TO DEFLECT AWAY FROM EACH OTHER IN A DIRECTION PERPENDICULAR TO THE AXIS OF ROTATION. THE COMPLAINT WAS CONFIRMED AS THE DRIVERS HAVE A CHOPPY OPERATION DURING USE. THE DRIVERS WERE ABLE TO INSERT A SCREW AND PERFORM ITS FUNCTION. THE MOST LIKELY UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED TO THE DRIVER. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2017-00044.

    Description of Event or Problem · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A THORACOTOMY FOR LUNG RESECTION AND RIB FIXATION TWO DRIVERS DID NOT TURN ADEQUATELY. IT WAS REPORTED THE DRIVERS WERE ABLE TO BE USED THOUGH THE END OF THE SURGERY. THERE WAS NO SURGICAL DELAY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36945 90 DEGREE CONTRA ANGLE SCREWDRIVER CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 306850

    Patients

    Seq Age Sex Outcome Treatment
    1