BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 12131915 · Received July 7, 2021

    Report

    Report Number
    0001811755-2021-00778
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    February 1, 2021
    Report Date
    October 27, 2021
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH MW 5101092 THAT DURING AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION) SURGICAL PROCEDURE, THE DRILL BIT BROKE WHILE SURGEON WAS ACTIVELY DRILLING. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT PIECE WAS LODGED INTO THE PATIENT¿S BONE. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO EXTRACT THE BROKEN PIECE, AN X-RAY CONFIRMED SUCCESSFUL REMOVAL.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH MW5101092 THAT DURING AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION) SURGICAL PROCEDURE, THE DRILL BIT BROKE WHILE SURGEON WAS ACTIVELY DRILLING. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT PIECE WAS LODGED INTO THE PATIENT¿S BONE. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO EXTRACT THE BROKEN PIECE, AN X-RAY CONFIRMED SUCCESSFUL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023417 UNKNOWN_INSTRUMENTS_PRODUCT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R