BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR DRILL BITS

    MDR report key: 3002435 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-00864
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PART OR LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A QUICK COUPLING FOR DRILL BITS. IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, THE QUICK COUPLING ATTACHMENT HEAD FELL OFF AND BROKE INTO PIECES. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105057 QUICK COUPLING FOR DRILL BITS HWE SYNTHES GMBH MA2027

    Patients

    Seq Age Sex Outcome Treatment
    1