BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY DRILL BIT 35MM

    MDR report key: 8386223 · Received March 1, 2019

    Report

    Report Number
    MW5084593
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 25, 2019
    Report Date
    February 28, 2019
    Manufacturer
    DEPUY SYNTHES INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS DRILLING A SCREW HOLE FOR THE ACETABULAR CUP LINER THE TIP OF THE DRILL BIT BROKE OFF. THE BROKEN PIECE WAS SUCTIONED UP FROM THE SURGICAL FIELD. THE EVENT CAUSED NO HARM/INJURY TO THE PATIENT. THE DRILL BIT WAS BEING USED DURING HIP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174118 DEPUY DRILL BIT 35MM BIT, DRILL HTW DEPUY SYNTHES INC PG277953

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR