BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT-3.5-HEX L180

    MDR report key: 3191894 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03486
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    September 12, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART BROKE DURING SURGERY. THERE WAS NO IMPACT UPON THE PATIENT IT WAS JUST THE END OF THE SCREW DRIVER SHAFT SNAPPED OFF DURING THE SURGERY, IT WAS REMOVED FROM THE SCREW IN THE PATIENT AND A DIFFERENT SCREW DRIVER WAS USED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290188 SCRDRIVERSHAFT-3.5-HEX L180 HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1