BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 3542290 · Received December 30, 2013

    Report

    Report Number
    8030965-2013-05567
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    November 29, 2013
    Report Date
    December 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED A REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND DURING MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(4); THAT DURING THE SURGERY ON (B)(6) 2013 THE TIP OF THE SCREWDRIVER AT THE DISTAL END BROKE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680157 SCREWDRIVER BIHEX Ø3 W/T-HANDLE HXX SYNTHES GMBH 3511558

    Patients

    Seq Age Sex Outcome Treatment
    1