BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 7013855 · Received November 9, 2017

    Report

    Report Number
    3005180920-2017-00644
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 10, 2017
    Report Date
    December 15, 2017
    Manufacturer
    HPF S.P.A.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED ON 23 NOVEMBER 2017: THE BAYONET DRILL WAS BROKEN, THE CAUSE OF THE BREAKING MIGHT BE AN EXCESS OF FLEXION DURING ITS USE.

    Additional Manufacturer Narrative · 1

    ON 24 OCTOBER 2017, HPF PROVIDED A DOCUMENT REVIEW REPORTING 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 RECEIVED OTHER COMPLAINT FOR THIS BATCH. CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. INSPECTION: ANALYZING THE AVAILABLE PICTURE, THE DRILL BROKE IN 2 PIECES. CONCLUSION: WE SUPPOSE THAT THE RUPTURE COULD BE CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE. THE MEDICAL AFFAIRS COMMENTED AS FOLLOWS: DURING SURGERY THE DRILL BIT BROKE. ACCORDING TO THE REPORT, ALL THE PIECES WERE RECOVERED AND NO DELAY IN SURGERY WAS RECORDED. HENCE, IN THIS CASE, THE CLINICAL EVALUATION IS NOT DUE. ON 08 NOVEMBER 2017 THE R&D PROJECT MANAGER PROVIDED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: THE BAYONET DRILL WAS BROKEN, THE CAUSE OF THE BREAKING MIGHT BE AN EXCESS OF FLEXION DURING ITS USE.

    Description of Event or Problem · 1

    DURING THE SURGERY THE DRILL BIT BROKE IN TWO PIECES. ALL PIECES WERE RECOVERED. NO PATIENT HARM AND NO DELAY IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    DURING THE SURGERY THE DRILL BIT BROKE IN TWO PIECES. ALL PIECES WERE RECOVERED. NO PATIENT HARM AND NO DELAY IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795092 VERSAFITCUP GENERAL 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 Other