BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 7112594 · Received December 13, 2017

    Report

    Report Number
    3005180920-2017-00737
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 13, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON NOV 27, 2017 HPF PROVIDED THE DOCUMENT REVIEW WITH THE FOLLOWING OUTCOME: DOCUMENT REVIEW BATCH RELEASED ON DATE: 05/05/2017. N. OF PIECES RELEASED: (B)(4) COMMENTS: 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: HPF HAVE NOT RECEIVED THE DEVICE. THE INSPECTION WAS NOT POSSIBLE. CONCLUSION: NOT HAVING THE POSSIBILITY TO ANALYZE THE DEVICE, WE SUPPOSE THAT THE RUPTURE COULD HAVE BEEN CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE. WE ARE NOW DOING SOME TEST TO VERIFY IF IT IS POSSIBLE TO TAKE ACTION ON THE MECHANICAL CHARACTERISTIC OF THE DEVICE (RESILIENCE AND/OR HARDNESS) TO IMPROVE ITS RESISTANCE.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS DRILLING FOR A SCREW, THE DRILL BIT BROKE. THE SURGEON WAS ABLE TO RECOVER ALL BROKEN PIECES. THE SURGEON USED A SECONDARY DRILL BIT TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A 10 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891266 FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 17H6305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other