BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 6646015 · Received June 16, 2017

    Report

    Report Number
    3005180920-2017-00310
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 17, 2017
    Report Date
    July 27, 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 09 JUNE 2017 HPF SPA PROVIDED A DOCUMENT FOR THE LOT INVOLVED IN THIS COMPLAINT, REPORTING AS FOLLOWS: BATCH RELEASED ON DATE: 22/09/2014. 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 ALREADY RECEIVED OTHER COMPLAINT FOR THIS BATCH. CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW.

    Additional Manufacturer Narrative · 1

    ON 03 JULY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE BAYONET DRILL WAS BROKEN, THE CAUSE OF THE BREAKING MIGHT BE AN EXCESS OF FLEXION DURING ITS USE. ON 03 JULY 2017 MEDACTA INTERNATIONAL INFORMED HPF SPA, THE MANUFACTURER OF THE ITEM INVOLVED IN THIS COMPLAINT, OF THE RECEIPT OF THE INSTRUMENT AND HPF REPLIED THEY DON'T NEED THE INSTRUMENT FOR VISUAL INSPECTION SINCE THE ISSUE IS A KNOWN EVENT AND THEY CONFIRM THAT, ANALYZING THE PICTURE, THE DRILL GOT BROKEN. THEY CONCLUDE THAT THE RUPTURE COULD BE CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE.

    Description of Event or Problem · 1

    WHILE DRILLING THE ACETABULUM, THE DRILL TIP BROKE. THE SURGEON HAD TO REMOVE THE CUP TO RECOVER THE TIP. THE TIP WAS RECOVERED FROM THE PATIENT. THERE WAS A 15 MINUTE DELAY INS SURGERY. THE SURGEON USED ANOTHER DRILL BIT TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426986 FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 14H8258

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other