BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHED

    MDR report key: 16530131 · Received March 13, 2023

    Report

    Report Number
    3003764610-2023-00010
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 13, 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

    PRODUCT HAD BEEN IN USE FOR 6 MONTHS WHEN COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. PATIENT STUMBLED BUT DID NOT FALL OR SUSTAIN INJURIES. PRODUCT WAS NOT RETURNED FOR INVESTIGATION SINCE IT HAD BEEN DISCARDED. UNHARDENED GUIDE PLATE LIKELY CONTRIBUTED TO PREMATURE WEAR OF LOCK, 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. THE MAJORITY OF CLAIMS REGARDING THIS ISSUE WERE NOT ASSOCIATED WITH AN INCIDENT, BUT DISCOVERED IN A TIMELY MANNER.

    Description of Event or Problem · 0

    GRADUAL ISSUE, INITIALLY LOCK WAS REPORTED TO BE WORKING INTERMITTENTLY AND WAS SERVICED. ONE WEEK LATER THE LOCK WAS NOT HOLDING THE PIN AT ALL AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576671 ICELOCK 621 RATCHED PROSTHETIC LOCK ISH OSSUR HF L-621000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown