BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 3020702 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-11040
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    April 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON WAS USING THE SCREWDRIVER AND THE HANDLE BEGAN SPINNING ON THE SHAFT. THE SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123468 STARDRIVE(TM) SCREWDRIVER T15 HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1