BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGEE DIGIT WIDGET

    MDR report key: 7079047 · Received December 4, 2017

    Report

    Report Number
    2919128-2017-00001
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 18, 2017
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A RAISED NOTCH ON THE SHAFT OF THE DISTAL PIN WAS DISCOVERED MAKING EFFECTIVE DIAMETER LARGER THAN THE INNER DIAMETER OF THE DISTAL GUIDE TUBE. THIS NOTCH PREVENTED REMOVAL OF THE DRILL GUIDE. THE INTERFERENCE FIT THEN PREVENTED THE PIN FROM DISLODGING FROM THE DRILL GUIDE. ROOT CAUSE FOR THE PRESENCE OF THE RAISED NOTCH WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET TO STRAIGHTEN A FLEXION CONTRACTURE. SURGEON CONTACTED HAND BIOMECHANICS LAB, INC. FROM THE OPERATING ROOM. THE DISTAL PIN "STUCK" IN THE DRILL GUIDE. WHEN FORCE WAS APPLIED TO REMOVE THE DRILL GUIDE, THE DISTAL PIN, STILL ATTACHED TO THE DRILL GUIDE, PULLED OUT OF THE BONE RESULTING IN WHAT THE SURGEON CALLED "A CATASTROPHIC FAILURE OF THE BONE". THE CASE WAS ABANDONED. FINGER WAS IMMOBILIZED AND PROTECTED BEFORE PATIENT WAS DISCHARGED. SURGEON INDICATED RESISTANCE INCREASED WHEN THREADING THE DISTAL PIN INTO THE BONE. INTRAOPERATIVE PICTURES INDICATE PIN PROFILES, ANGLES AND PLACEMENT WERE PROPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859918 AGEE DIGIT WIDGET EXTERNAL FIXATION DEVICE JDW HAND BIOMECHANICS LAB, INC. DWD-114-199B

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention