BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC Ø0.6-3.2 F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 4183107 · Received October 17, 2014

    Report

    Report Number
    8030965-2014-01523
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE COUPLING POWER SUPPLY WAS DAMAGED AND INADEQUATE SLIDING. PARTS WERE REPLACED. UNIT WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN GRAPPING K WIRE, THE SLIDING CHARACTERISTIC OF K WIRE WAS POOR. IT WAS SMOOTH ALONG PLUGGING DIRECTION (FROM TIP OF THE K WIRE TO MAIN BODY DIRECTION), WHILE IT DIDN¿T MOVE WELL ALONG THE OPPOSITE DIRECTION (PULLING OUT DIRECTION AFTER K WIRE INSERTION IN REAL SURGERY SITUATION). THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661160 QC Ø0.6-3.2 F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 1954

    Patients

    Seq Age Sex Outcome Treatment
    1