BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE

    MDR report key: 3241456 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04436
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON INSERTED THE SCREW WITH THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DRILL SLEEVE INTO THE DISTAL ROW MOST STYLOID HOLE BY HAND; HOWEVER, THE SCREW WAS NOT LOCKED AND PENETRATED. THE SURGEON WAS UNABLE TO IDENTIFY THE SCREW SIZE, BUT VISUALLY CONFIRMED THAT TORQUE THROUGH. THE SURGEON REMOVED THE PENETRATED SCREW IN THE DORSAL APPROACH AND USED ANOTHER SCREW. THE SURGEON WAS UNCOMFORTABLE WITH THE SCREW, BUT IT COULD BE SET IN THE PLATE. TORQUE LIMITER WAS USED IN LOCKING. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340309 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE HWC SYNTHES USA 8340290

    Patients

    Seq Age Sex Outcome Treatment
    1