BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 6151277 · Received December 7, 2016

    Report

    Report Number
    3005180920-2016-00642
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 8, 2016
    Report Date
    January 4, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RELEASE FROM THE MANUFACTURER ON 25 NOVEMBER 2016: BATCH RELEASED ON DATE: 30/06/2016. 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. NO OTHER COMPLAINT RECEIVED FOR THIS BATCH. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW.

    Additional Manufacturer Narrative · 1

    ON 09 DECEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: ACCORDING TO REPORT, A DRILL BIT GOT FRACTURED DURING ACETABULAR SCREW HOLE PREPARATION AND COULD NOT BE RETRIEVED WITHOUT INDUCING SIGNIFICANT DAMAGE, SO THE SURGEON DECIDED THAT IT WAS BEST FOR THE PATIENT TO LIVE WITH THE DRILL BIT BURIED IN THE BONE. THE DRILL BIT IS NOT MADE OF A MATERIAL APPROVED FOR LONG-TERM IMPLANTATION, HOWEVER NO MAJOR DAMAGE SHOULD BE EXPECTED, PARTICULARLY GIVEN THE VERY SHELTERED SITUATION WHERE IT LIES. ALSO, THE MECHANICAL FRETTING BETWEEN CUP AND DRILL BIT IS NOT AUSPICABLE, BUT AGAIN IT CAN BE WISHED THAT IT SHOULD BE OF LIMITED ENTITY, AND THAT IT WILL NOT RECEDE TO TOUCH THE INSERT. ALL IN ALL, NOT A VERY HAPPY SITUATION, BUT THE SURGEON'S CHOICE TO LEAVE IT THERE WAS CERTAINLY BASED ON REASONED WEIGHING OF PRO'S AND CONT'S AND CANNOT BE QUESTIONED NOW BY ME. THE CAUSE FOR THE FRACTURE IS UNKNOWN; IF THE FRACTURED BIT IS MADE AVAILABLE A STUDY ON THE FRACTURE SURFACE COULD BE EXECUTED, BUT BEING A CUTTING TOOL IT IS TO BE EXPECTED THAT THE FRACTURE TYPE WILL BE FRAGILE AND THAT IT WAS CAUSED BY BENDING. NO OTHER CONCLUSION CAN BE MADE; IT'S A VERY UNUSUAL SITUATION FOR A COMMON INSTRUMENT IN THE HANDS OF AN EXPERIENCED SURGEON.

    Description of Event or Problem · 1

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT BROKE INSIDE THE ACETABULAR BONE WHILE THE SURGEON WAS DRILLING TO PREPARE FOR A SCREW. THE SURGEON COULD NOT RETRIEVE IT AND DECIDED TO LEAVE IT IN THE PATIENT. THE SURGEON PROCEEDED TO PUT IN ANOTHER SCREW AND THE POLY LINER, CONFIDENT THAT THE DRILL WOULD NOT MOVE AS IT WAS BURIED IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803074 FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF S.P.A. 16H7425

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other