BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 14547699 · Received May 31, 2022

    Report

    Report Number
    2919128-2022-00002
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    April 30, 2022
    Report Date
    May 31, 2022
    Manufacturer
    HAND BIOMECHANICS LAB, INC.
    Product Code
    JDW
    UDI-DI
    00861994000212
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOSPITAL DID NOT COMPLY WITH SURGEONS WISHES AND DISPOSED TO DRILL GUIDE. EFFORTS TO OBTAIN X-RAYS TO FACILITATE OUR INVESTIGATION FAILED.

    Description of Event or Problem · 0

    PATIENT HAD SURGERY TO INSTALL A DIGIT WIDGET EXTERNAL FIXATION SYSTEM. SURGEON CALLED TO REPORT HE WAS UNABLE TO INSTALL THE DISTAL BONE PIN DUE TO AN OBSTRUCTION IN THE DRILL GUIDE TUBE. HE SAID X-RAYS SHOWED AN "OCCLUDED HOLE" AND THE OBJECT LOOKED LIKE A DRILL BIT. SURGEON WAS ABLE TO COMPLETED THE CASE WITH PARTS FROM A 2ND DIGIT WIDGET SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2685755 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB, INC. DWD-232 DWD-121-105A 00861994000212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention