BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 7137290 · Received December 21, 2017

    Report

    Report Number
    3005180920-2017-00761
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 21, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE 11TH DECEMBER 2017 (B)(4) REPORTED TO MEDACTA THE FOLLOWING INVESTIGATION: BATCH RELEASED ON DATE: 17JAN/2017. N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. INSPECTION: WE HAVE ALREADY RECEIVED COMPLAINTS FOR THIS CODE AND BATCH. THE PIECE WAS NOT AVAILABLE FOR ANALYSIS, BUT LOOKING AT THE PICTURE, THE DRILL BROKE IN 2 PIECES. CONCLUSION: WE SUPPOSE THAT THE RUPTURE COULD HAVE BEEN CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE.

    Description of Event or Problem · 1

    DURING SURGERY WHILE DRILLING FOR A SCREW. THE DRILL BIT BROKE. NO ADDITIONAL INSTRUMENTATION REQUIRED AS HE WAS DONE USING THE DRILL BIT. THERE WAS NO DELAY IN THE CASE. ALL FRAGMENTS WERE RECOVERED. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916501 FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 17H0687

    Patients

    Seq Age Sex Outcome Treatment
    1 Other