BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6255710 · Received January 17, 2017

    Report

    Report Number
    0001032347-2017-00047
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Report Date
    January 13, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCE WERE FOUND. VISUAL INSPECTION IDENTIFIED MODERATE USE. THE PRODUCT WAS FUNCTIONALLY TESTED USING A CONTRA ANGLE 2.0 MM HT X-LOCK BLADE (PART #20-1193) TO DRIVE A 2.0 SCREW AND INTO A BLOCK OF WHITE OAK. THE DRIVER WAS ABLE TO INSERT THE SCREW. HOWEVER, DIFFICULTY WAS EXPERIENCED WHILE ATTEMPTING TO REMOVE THE BLADE FROM THE HEAD ASSEMBLY. THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS WEAR TO THE BLADE LOCKING MECHANISM IN THE HEAD ASSEMBLY OVER THE COURSE OF NORMAL USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATES IN THE SECTION TITLED WARNINGS AND PRECAUTIONS: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR ASSOCIATE REPORTED THE DRIVER WAS TESTED AND FOUND TO NOT FUNCTION. THERE IS NO SURGERY OR PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41222 90 DEGREE CONTRA ANGLE SCREWDRIVER CONTRA ANGLE SCREWDRIVER JEY BIOMET MICROFIXATION N/A 591220

    Patients

    Seq Age Sex Outcome Treatment
    1