BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED 3.5MM HEXAGONAL SCREWDRIVER

    MDR report key: 3030008 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01762
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE SHAFT COMPONENT, PART#314.19.01, WAS MADE FROM (B)(4) WHICH IS A TYPICAL MATERIAL USED TO MAKE CANNULATED SCREWDRIVER SHAFTS. THIS IS THE 16TH COMPLAINT FOR THIS CONDITION IN THE ENTIRE COMPLAINT HISTORY AND APPROXIMATELY (B)(4) HAVE BEEN DISTRIBUTED SINCE RELEASE RESULTING IN AN ESTIMATED COMPLAINT RATE OF (B)(4) BASED ON SALES. THIS DEVICE IS USED REPEATEDLY SO THE ACTUAL COMPLAINT RATE BASED ON USAGE WOULD BE SIGNIFICANTLY LOWER. THE RETURNED DEVICE IS AT LEAST 20 YEARS OLD, AND HAS OUTLIVED ITS USEFUL LIFE.

    Description of Event or Problem · 1

    DURING A SURGERY TO IMPLANT A 7.0MM CANNULATED SCREW, WHILE IN THE MIDDLE OF THE FINAL TURN OF THE SCREWDRIVER, THE TIP OF THE SCREWDRIVER BROKE OFF INTO THE HEAD OF THE CANNULATED SCREW. REPORTEDLY, THE GUIDE WIRE WAS STILL IN PLACE. THE SURGEON REMOVED THE PIECE OF SCREWDRIVER FROM THE HEAD OF THE SCREW AND HE THEN REMOVED THE GUIDE WIRE. THE SCREW WAS TIGHTENED DOWN AND NO ADDITIONAL TIGHTENING WAS NEEDED. IT WAS REPORTED AN ADDITIONAL 20 MINUTES WAS ADDED TO THE SURGERY.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134215 CANNULATED 3.5MM HEXAGONAL SCREWDRIVER HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention