BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED TRINKLE DRILLING ATTACH FOR BATTERY POWER

    MDR report key: 2914190 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01502
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KIJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS NOT RETURNED, NO CONCLUSION WAS DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SYNTHES: SURGEON WAS USING THE MODIFIED TRINKLE DRILLING ATTACHMENT FOR A TOTAL KNEE PROCEDURE. THE ATTACHMENT BROKE INTO PIECES. IT WAS REPORTED THERE WAS NO PATIENT HARM WITH ANOTHER DRILL BEING USED TO COMPLETE THE PROCEDURE WITH NO DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED TRINKLE DRILLING ATTACH FOR BATTERY POWER MODIFIED TRINKLE DRILLING ATTACH KIJ SYNTHES GMBH 3367683

    Patients

    Seq Age Sex Outcome Treatment
    1