BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHED

    MDR report key: 16511813 · Received March 9, 2023

    Report

    Report Number
    3003764610-2023-00009
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 9, 2023
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOCK FAILED AFTER 3 WEEKS USE, NO INJURY OCCURRED. THE LOCKING PLATE AND LOCKING PINS WERE FOUND WORN. PRODUCT WEAR IS A KNOWN DISADVANTAGE WITH RATCHET LOCK WHERE UNHARDENED GUIDE PLATE MAY HAVE BEEN MORE SUSCEPTIBLE TO A BINDING EFFECT BETWEEN SIMILAR STAINLESS-STEEL MATERIAL AND SUBSEQUENT FASTER WEAR DOWN. CAPA IS IN PROGRESS AND PRODUCT IMPROVEMENTS HAVE BEEN IMPLEMENTED. FAILING LOCK CAN LEAD TO SERIOUS INJURY, BUT ISSUE IS EXPECTED TO BE DISCOVERED BY THE USER BEFORE BECOMING HAZARDOUS AS THE WEAR OCCURS GRADUALLY OVER TIME AND CHANGE IN USE OF THE LOCKING MECHANISM IS LIKELY TO BE NOTICED BY THE USER. INSTRUCTIONS FOR USE INDICATES A WARNING FOR CHANGE OR LOSS IN DEVICE FUNCTIONALITY, AND TO CONTACT A CLINICIAN WHEN THIS OCCURS.

    Description of Event or Problem · 0

    PRODUCT HAD BEEN IN USE FOR 3 WEEKS WHEN THE COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707351 ICELOCK 621 RATCHED PROSTHETIC LOCK ISH OSSUR HF L-621000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown