BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6174923 · Received December 15, 2016

    Report

    Report Number
    0001032347-2016-00754
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 2, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LOT AND NO NON-CONFORMANCES WERE FOUND. THE DRIVER WAS VISUALLY EVALUATED AND IT SHOWS SIGNS OF NORMAL USE. THE COMPLAINT WAS CONFIRMED AS WHEN THE HANDLE (KNOB) WAS ROTATED AN INSERTED BLADE DID NOT ROTATE. IT WAS NOTICED THAT THE HEAD OF THE DRIVER WAS A LITTLE LOOSE AND ABLE TO BE SCREWED BACK INTO THE HANDLE. THE LOOSE HEAD WOULD CAUSE THE HEX NOT TO ENGAGE PROPERLY. AFTER THIS, WHEN THE KNOB WAS ROTATED AN INSERTED BLADE WOULD ROTATE. THE DRIVER WAS THEN TESTED WITH A BLADE, A SCREW, AND POPLAR. THE BLADE COULD BE SUCCESSFULLY INSERTED INTO THE DRIVER. THE SCREW WAS INSERTED AND REMOVED FROM THE POPLAR WITH NO ISSUES. THE COMPLAINT IS CONFIRMED AS UPON RECEIPT THE DRIVER WOULD NOT TURN A BLADE. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE LOOSENING OF THE HEAD FROM THE HANDLE.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE PRODUCT RETURN, THE FOLLOWING WERE UPDATED: MODEL #/LOT #, DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR?, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, DEVICE MANUFACTURE DATE, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. 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.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    (IN ADDITION TO WHAT WAS ALREADY REPORTED) IT WAS CONFIRMED THAT THIS WAS A RIBFIX CASE.

    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 THERE WAS INTERMITTENT BINDING OF THE SCREW DRIVER MECHANISM. THE BACK UP DRIVER WAS USED TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A TWO MINUTE SURGICAL DELAY AND NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827873 90 DEGREE CONTRA ANGLE SCREWDRIVER CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 618770

    Patients

    Seq Age Sex Outcome Treatment
    1