BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS DRILL BIT INSTRUMENT

    MDR report key: 3682621 · Received March 5, 2014

    Report

    Report Number
    3006460162-2014-00001
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    December 2, 2013
    Report Date
    January 14, 2014
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HTW
    PMA / PMN Number
    K083726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION CONCLUSION: RISK OF POTENTIAL OR ACTUAL SERIOUS HARM IS NOT SIGNIFICANT: PROVIDE RATIONALE: DRILL BIT WAS BEING USED "OFF LABEL." USER ERROR RESULTED IN DRILL BIT BREAKING. THE ADVERSE EVENT OF EXCESSIVE BLOOD LOSS WAS CAUSED POST MALFUNCTION (DRILL BIT FRACTURE) WHEN THE SURGEON NICKED THE FEMORAL ARTERY ATTEMPTING TO REMOVE THE RETAINED PORTION OF THE DRILL BIT FROM BONE. BLEEDING STOPPED ON IT'S OWN WITHOUT INTERVENTION OF VASCULAR SURGEON. DRILL BIT BREAKAGE WAS A CONTRIBUTING FACTOR BUT NOT THE ROOT CAUSE OF THE ADVERSE EVENT.

    Description of Event or Problem · 1

    SURGEON USING DRILL BIT OFF LABEL TO TAKE DOWN A POST-TRAUMATIC FEMORAL MALUNION WITH SIGNIFICANT OVERLAP/SHORTENING. DRILL BIT BROKE WITH 20MM LEFT IN BONE. IN TRYING TO REMOVE THE RETAINED PORTION OF THE DRILL, SURGEON APPARENTLY NICKED THE FEMORAL ARTERY. (B)(6)NUMBER PATIENT LOST 2 LITERS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131483 ORTHOPEDIATRICS DRILL BIT INSTRUMENT DRILL BIT HTW ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other