BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP GENERAL DRILL BIT Ø 3.2 L 130

    MDR report key: 8527550 · Received April 18, 2019

    Report

    Report Number
    3005180920-2019-00300
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 22, 2019
    Report Date
    July 16, 2019
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REQUEST FOR MANUFACTURING PROCESS DOCUMENT REVIEW HAS BEEN SENT TO THE SUPPLIER HPF ON 18.04.2019. DOCUMENT REVIEW RECEIVED REPORTED AS FOLLOWS: 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 NONCONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. THE INSTRUMENT HAS BEEN SENT TO THE SUPPLIER ON 08.05.2019. VISUAL INSPECTION PERFORMED BY R&D HIP MANAGER: THE INSTRUMENT IS BROKEN. IT IS POSSIBLE THAT THE BENDING FORCE APPLIED TO THE DRILL BIT WAS TOO HIGH PROVIDING A BREAKAGE OF THE INSTRUMENT, BUT WE DO NOT HAVE THE CERTAINTY OF THE ROOT CAUSE. VISUAL INSPECTION PREFORMED BY THE SUPPLIER HPF RECEIVED ON 19.06.2019: AS SHOWN IN THE PICTURE, THE DRILL BIT BROKE. AS CONFIRMED BY THE CUSTOMER THE DRILL BIT WAS MOVED FROM THE HOLE TOO EARLY AND OUT OF ALIGNMENT; DUE TO THE FLEXION AND THE CONSEQUENT PRESSURE THE DEVICE BROKE. THE DEVICE WAS USED NOT IN A PROPER WAY. ON JULY 16, AT THE TIME OF FU2 SENDING, WE REALIZED THAT FU1 PREPARED ON MAY 24TH FAILED DURING SENDING PROCESS. WE UPDATED FU2 WITH ALL THE INFORMATION PRESENT IN FU1.

    Description of Event or Problem · 1

    DRILL BIT BROKE DURING THE PROCESS OF EXTRACTING THE BIT FOLLOWING DRILLING. THE SURGEON MOVED THE DRILL OUT OF ALIGNMENT TOO EARLY RESULTING IN PRESSURE ON THE BIT AND IT SNAPPING. THE INSTRUMENT WAS NO LONGER FIT FOR PURPOSE DUE TO WEAR AND TEAR. NO DEBRIS WENT INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318885 HIP GENERAL DRILL BIT Ø 3.2 L 130 SURGICAL INSTRUMENT FOR HIP LXH HPF SPA 17H0523

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other