BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM THREADED GUIDE WIRE 150MM

    MDR report key: 2862220 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01503
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    DQX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION FOUND THAT THE FRONT PART WAS SHEARED OFF. THE REMAINING SHAFT SHOWS FRETTING MARKS. THE MICROSCOPIC INVESTIGATION SHOWS THAT THE WIRE WAS ERODED INTO A CONE END TILL IT WAS TOO WEAK AND SHEARED OFF. THE MANNER OF DAMAGE POINTS TO THE FACT THAT THE GUIDE WIRE WAS BENT TOO MUCH DURING DRILLING OR EXTENSIVE LATERAL STRESS WAS APPLIED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE WAS BROKEN DURING A SCAPHOID CASE. AHCS 3.0 WERE TO BE USED IN A SCAPHOID FRAGMENT. THE SURGEONS CAREFULLY INSERTED THE GUIDE WIRE THROUGH THE NEAR CORTEX OF THE SCAPHOID, THE FRAGMENT LINE, AND STOPPED IN THE FAR CORTEX. HOWEVER, WHEN THE CANNULATED DRILL BIT WAS USED, THE GUIDE WIRE BROKE BETWEEN THE NEAR CORTEX AND THE FRAGMENT LINE. THE SURGEON COULD NOT EXTRACT THE BROKEN GUIDE WIRE AND FINISHED THE CASE BY POSITIONING ANOTHER HCS 3.0 NEXT TO THE BROKEN GUIDE WIRE. THE BROKEN FRAGMENT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1MM THREADED GUIDE WIRE 150MM 1.1MM THREADED GUIDE WIRE DQX SYNTHES GMBH 8063867

    Patients

    Seq Age Sex Outcome Treatment
    1