BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 11599922 · Received March 31, 2021

    Report

    Report Number
    3008650117-2021-00075
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    June 15, 2020
    Report Date
    March 31, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HTJ
    PMA / PMN Number
    K190365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOT NUMBER 9151337 WERE REVIEWED AND SHOWS ALL INSPECTED PARTS WERE RECEIVED AND ACCEPTED. VISUAL OBSERVATION OF THE INSTRUMENT CONFIRMED THE DEPTH GAUGE BROKEN INTO PIECES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    A PARGON 28 DEPTH GAUGE PLATE SCREW, 70MM SCREW WAS REPORTED BROKEN AFTER BEING WASHED. THE NEEDLE OF THE DEVICE IS SNAPPED OFF COMPLETELY. IT WAS REPORTED THAT THE INSTRUMENT WAS NOT BROKEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497872 BABY GORILLA/GORILLA PLATING SYSTEM DEPTH GAUGE PLATE SCREW, 70MM SCREW HTJ PARAGON 28, INC. P99-150-0014 9151337

    Patients

    Seq Age Sex Outcome Treatment
    1