BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS PEDIFRAG SYSTEM 3.5MM, 2.0MM DRILL BIT

    MDR report key: 5825586 · Received July 22, 2016

    Report

    Report Number
    MW5063675
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 22, 2016
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIATRICS 2.0 DRILL BIT #01-1005-003, LOT # 00QXY-D, TIP BROKE DURING USE WHILE DRILLING A SCREW HOLE INTO THE PT'S CALCANEUS AND BECAME IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469966 ORTHOPEDIATRICS PEDIFRAG SYSTEM 3.5MM, 2.0MM DRILL BIT PEDIFRAG SYSTEM 3.5 MM HRS ORTHOPEDIATRICS PEDIFRAG SYSTEM 00QXY-D

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR