BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM STARDRIVE SCREWDRIVER SHAFT

    MDR report key: 3020753 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10530
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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

    THIS IS REPORT 2 OF 2 FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO INSTRUMENTS MALFUNCTIONED DURING SURGERY. THE MINI QUICK COUPLING HANDLE WAS STICKING AND THE T-8 STARDRIVE SHAFT WAS STUCK IN THE HANDLE. THE SURGEON HAD TO USE PLIERS AND A MALLET TO DISCONNECT THE TWO INSTRUMENTS. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123966 2.4MM STARDRIVE SCREWDRIVER SHAFT HXX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1