BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 6672557 · Received June 28, 2017

    Report

    Report Number
    3005180920-2017-00341
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 28, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12 JUNE 2017, HPF SPA PROVIDED A DOCUMENT REVIEW AND A PRELIMINARY INVESTIGATION FOR THE PRODUCT INVOLVED IN THE COMPLAINT AND COMMENTED AS FOLLOWS: BATCH RELEASED ON DATE: 17/01/2017. 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. WE HAVE RECEIVED OTHER COMPLAINT FOR THIS BATCH. CONCLUSIONS: 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.

    Description of Event or Problem · 1

    DURING SURGERY WHEN THE SURGEON WAS DRILLING FOR A SCREW THE DRILL BIT BROKE. THE DRILL BIT FELL INTO THE PATENT. THE SURGEON WAS ABLE TO RECOVER ALL COMPONENTS. THE SURGERY WAS DELAYED APPROXIMATELY 1 MINUTE. THE SURGEON USED A SECONDARY DRILL BIT TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453069 MPACT 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 55 YR Other