BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHET

    MDR report key: 16478029 · Received March 3, 2023

    Report

    Report Number
    3003764610-2023-00007
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 15, 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

    PREMATURE PRODUCT WEAR RESULTED IN LOCK NOT PROVIDING SECURE SUSPENSION. PRODUCT HAD BEEN IN USE FOR 4 MONTHS. USER DEVELOPED SKIN REACTION ON THE RESIDUAL LIMB FROM HOBBLING AROUND WHILE ON HOLIDAY. PLAY AND PREMATURE LOCKING PLATE WEAR HAS BEEN IDENTIFIED AS LIKELY ROOT CAUSE OF FAILURE. CAPA IS IN PROGRESS TO ADDRESS ISSUES WITH PREMATURE WEAR OF THE LOCK. PREMATURE WEAR 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

    LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.

    Description of Event or Problem · 0

    LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.

    Description of Event or Problem · 0

    LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732023 ICELOCK 621 RATCHET PROSTHETIC LOCK ISH OSSUR HF L-621000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly