BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6381101 · Received March 6, 2017

    Report

    Report Number
    0001032347-2017-00169
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 6, 2017
    Report Date
    December 10, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED IN A BIOHAZARD BAG AND THEREFORE COULD NOT BE FUNCTIONALLY TESTED. THE PRODUCT HANDLE WAS TURNED THROUGH THE BAG AND NO RESISTANCE WAS FELT. THE MOST LIKELY CAUSE OF THE OF THE COMPLAINT COULD NOT BE DETERMINED.

    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.

    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 IS REPORTED THE INTERNAL MECHANISM OF THE CONTRA ANGLE DRIVER BROKE AND THE WHEEL NO LONGER ROTATED THE BLADE. THE ADDITIONAL CONTRA ANGLE DRIVER IN THE SET WAS USED TO COMPLETE THE SURGERY. THERE WAS A TWENTY MINUTE DELAY. THE DISTRIBUTOR ASSOCIATE STATED THE RESIDENT WHO WAS USING THE DRIVER WAS NOT TURNING THE WHEEL OVER EXTENSIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164007 90 DEGREE CONTRA ANGLE SCREWDRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 056380

    Patients

    Seq Age Sex Outcome Treatment
    1