BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER

    MDR report key: 2983434 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-01240
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT HAD A FRACTURE OF THE DISTAL RADIUS. ON (B)(6) 2013, THE PATIENT HAD A PROCEDURE DONE ON THE FRACTURED DISTAL RADIUS, WHERE THE SURGEON VA-TCP. WHEN THE DOCTOR WAS JUST ABOUT TO OPEN A PACKAGE OF VA LOCKSCR 2.4 SELF-TAP L16 TAN AND BEGIN TO USE. HOWEVER, THE SCREW DID NOT FIT RIGHT IN WITH THE DRIVER. THE DOCTOR INSERTED THE SCREW THINKING THAT STARDRIVE WAS NOT THE SAME IN SHAPE. THE SHAPE OF STARDRIVE WAS A LITTLE BIT BIGGER THAN PROPER ONE, THE DRIVER RUN IDLE AND STARDRIVE WAS BROKEN. THE SCREW IN QUESTION WAS REPLACED WITH ANOTHER ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS REPORT 1 OF 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86175 STARDRIVE SCREWDRIVER HXX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1