BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURNKEY FCS

    MDR report key: 7113183 · Received December 13, 2017

    Report

    Report Number
    2919128-2017-00003
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    September 11, 2015
    Report Date
    December 14, 2018
    Manufacturer
    HAND BIOMECHANICS LAB, INC
    Product Code
    JEC
    PMA / PMN Number
    K072432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DETERMINED DEVICE EVENT FROM 1 OF 9 POSSIBLE DEVICE LOTS. REVIEWED STERILIZATION AND STERILIE BARRIER INSPECTION RECORDS FOR ALL 9 LOTS. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED WARNING AND CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 0

    PHYSICAIN REPORTED A PATIENT ONCE HAD A PIN SITE 'INFECTION FROM SIDE TO SIDE MOVEMENT OF THE TRANSVERSE PIN THROUGH THE BONE'.

    Additional Manufacturer Narrative · 1

    DETERMINED DEVICE EVENT FROM 1 OF 9 POSSIBLE DEVICE LOTS. REVIEWED STERILIZATION AND STERILIE BARRIER INSPECTION RECORDS FOR ALL 9 LOTS. NO PATTERN RELATED TO IRRADIATION DOSE LOT OR DEVICE LOT WAS NOTED. CONFIRMED LABELING INCLUDED WARNING AND CAUTIONS REGARDING PIN SITE CARE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT ONCE HAD A PIN SITE 'INFECTION FROM SIDE TO SIDE MOVEMENT OF THE TRANSVERSE PIN THROUGH THE BONE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892378 TURNKEY FCS TURNKEY FCS JEC HAND BIOMECHANICS LAB, INC FCS-400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention