BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 STRAIGHT TIP W/HEX-CO

    MDR report key: 3171578 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03087
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE CHECKING OF MANUFACTURING DATA AND HARDNESS SPECIFICATIONS ALSO SHOWED THAT THERE WERE NO DEVIATIONS FROM THE SPECIFICATIONS. INVESTIGATION OF THE AFFECTED SCREWDRIVER HAS SHOWN THAT THE TIP WAS COMPLETELY BROKEN OFF BY EXCESSIVE TORSION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE INSTRUMENT BROKE OFF ON AN UNKNOWN DATE. THE BROKEN PARTS WERE RETRIEVED. IT IS UNKNOWN WHERE THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272439 SCRDRIVERSHAFT T25 STRAIGHT TIP W/HEX-CO HXX SYNTHES GMBH 1930001

    Patients

    Seq Age Sex Outcome Treatment
    1