BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3023724 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-01154
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART/SERIAL NUMBER COMBINATION UNKNOWN AT SYNTHES (B)(4), THEREFORE, NO DHR REVIEW POSSIBLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING ON (B)(6) 2013, DURING AN ORTHO PROCEDURE, THE QUICK COUPLING FOR K-WIRES ATTACHMENT WAS RUNNING INTERMITTENTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY, NO FURTHER PROBLEM, AND NO HARM TO PATIENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125892 QUICK COUPLING FOR K-WIRES HWE SYNTHES GMBH 09136

    Patients

    Seq Age Sex Outcome Treatment
    1