BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 5991652 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00508
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 1, 2016
    Report Date
    January 4, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 14 SEPTEMBER 2016, THE SUPPLIER PROVIDED A DOCUMENT REVIEW FOR THE PRODUCT INVOLVED IN THIS COMPLAINT, AND REPORTED AS FOLLOWS: BATCH RELEASED ON 20APR2015. 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. WE WAIT THE ARRIVAL OF THE BROKEN INSTRUMENT TO INVESTIGATE THE CAUSES OF THE BREAKAGE. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 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. THE INSTRUMENT WILL BE SHIPPED TO THE MANUFACTURER FOR AN IN-DEPTH ANALYSIS. ON (B)(6) 2016, MEDACTA INTERNATIONAL SA SENT THE RETRIEVED INSTRUMENT TO THE MANUFACTURER FOR FURTHER INVESTIGATIONS.

    Additional Manufacturer Narrative · 1

    ON 05 DECEMBER 2016, THE MANUFACTURER PROVIDED THE FINAL REPORT OF THE ANALYSIS PERFORMED ON THE INVOLVED ITEM AND REPORTED AS FOLLOWS: WE HAVE ALREADY RECEIVED COMPLAINTS FOR THIS CODE. THE DIMENSIONS OF THE DEVICE ARE CONFORM TO APPLICABLE SPECIFICATION. THE RUPTURE WAS ANALYZED AT THE MICROSCOPE AND THERE AREN'T SIGNS OF CRACKS ON THE MATERIAL. WE SUPPOSE 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

    WHEN THE SURGEON WAS DRILLING FOR A SCREW, THE DRILL BIT BROKE. THE SURGEON USED A SECONDARY DRILL BIT TO COMPLETE THE SURGERY. ALL PIECES WERE RECOVERED. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643538 FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 15H4189

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other