BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3960552 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-01044
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 13, 2014
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN. POWER TOOL EVALUATION WAS COMPLETE ON THIS DEVICE. THE CUSTOMER DID NOT ALLEGE OR IDENTIFY ANY SPECIFIC DEFICIENCY; AN UNUSUAL NOISE WAS OBSERVED DURING PRE-REPAIR EVALUATION OF THE ATTACHMENT OF THE DEVICE. EVIDENCE SUGGESTS THIS IS DUE TO USAGE WEAR OVER TIME. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE QUICK COUPLING FOR K-WIRES (532.022) LOT 09153 NEEDS REPAIR FOR AN UNSPECIFIED MALFUNCTION. THIS IS REPORT 1 OF 1 OF COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439209 QUICK COUPLING FOR K-WIRES HWE 09153

    Patients

    Seq Age Sex Outcome Treatment
    1 QUICK COUPLING FOR K-WIRES