BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3556384 · Received January 7, 2014

    Report

    Report Number
    2520274-2013-08003
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER: (B)(6). PRODUCT CODE: HSZ, GFA, GFF. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2013 DURING PLACEMENT SURGERY, THE SCREW WAS PLACED IN THE BONE. IT WAS MEASURED BY THE DEPTH GAUGE AND THE DRILL BIT MOUNTED ON THE WOODEN HANDLE WAS PASSED, MANUALLY DRILLED AND THE DRILL BIT BROKE. THE SCREW WAS ABLE TO BE PLACED. WHEN USING THE SAME PLACEMENT PROCEDURE, THE SECOND SCREW THE SECOND DRILL BIT BROKE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10316 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR