BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR ATTACHMENT-SHORT FOR PEN DRIVE

    MDR report key: 3030499 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01195
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE AS IT IS NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. MANUFACTURING EVALUATION REVIEWED, MDR REPORTABILITY STATUS UPDATED PER PMRM AND FS-932. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT # 8030965-2013-01195. PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THE BURR ATTACHMENT WOULD NOT SECURE THE CUTTER. REPORTEDLY THERE WAS A SPARE AVAILABLE. THERE WAS A TIME DELAY HOWEVER THE FACILITY WAS UNABLE TO PROVIDE THE TIME DELAY. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134888 BURR ATTACHMENT-SHORT FOR PEN DRIVE HWE SYNTHES GMBH 1462705

    Patients

    Seq Age Sex Outcome Treatment
    1