BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHED

    MDR report key: 16485802 · Received March 6, 2023

    Report

    Report Number
    3003764610-2023-00008
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    December 31, 2022
    Report Date
    March 10, 2023
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOCK FAILED TO PROVIDE SECURE SUSPENSION WHEN USER WAS WALKING, USER DID NOT FALL OR SUSTAIN ANY INJURIES BUT SHOULD A SIMILAR INCIDENT RECUR THERE IS A POSSIBILITY OF INJURY. PRODUCT HAD BEEN IN USE FOR 1 YEAR. LOCK WAS TESTED WITH A NEW PIN AND FOUND TO ENGAGE PIN SUCCESSFULLY. MINOR WEAR WAS IDENTIFIED ON LOCKING PLATE AND GUIDE PLATE DURING INSPECTION. DIRT WAS IDENTIFIED IN LOCKING MECHANISM WHEN LOCK WAS DISASSEMBLED. IT IS POSSIBLE THAT WORN ATTACHMENT PIN RESULTED IN PIN RELEASING FROM LOCK. UNABLE TO CONCLUDE ON ROOT CAUSE SINCE THE ATTACHMENT PIN WAS NOT RETURNED WITH THE LOCK.

    Description of Event or Problem · 0

    PATIENT WAS WALKING AND PIN RELEASED FROM LOCK WITHOUT WARNING. NO INJURY OCCURRED.

    Description of Event or Problem · 0

    PATIENT WAS WALKING AND PIN RELEASED FROM LOCK WITHOUT WARNING. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512467 ICELOCK 621 RATCHED PROSTHETIC LOCK ISH OSSUR HF L-621000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown