BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRUTCH, ALUMINUM, ADULT MEDIU

    MDR report key: 1637742 · Received March 3, 2010

    Report

    Report Number
    1417592-2010-00009
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 1, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    END USER WAS RECOVERING FROM LEFT KNEE ACL REPLACEMENT AND MENISCUS REPAIR. HE WAS AMBULATING WITH THE CRUTCHES WHEN ONE OF THE CRUTCHES SUDDENLY BROKE AND HE FELL ONTO HIS KNEE. HE WENT TO THE EMERGENCY ROOM AND NO FRACTURE WAS IDENTIFIED. FOLLOW UP APPOINTMENTS TO HIS PHYSICIAN INDICATED THAT HE DID NOT RE-INJURE HIS ACL AND THE SURGICAL SCREWS WERE FOUND TO REMAIN IN PLACE. NO FURTHER SURGICAL INTERVENTION WILL BE INDICATED. THEY DID FIND THAT HE TORE HIS MCL. THE CRUTCH WAS EVALUATED AND CONFIRMED THAT IT HAD BROKEN AT ONE OF THE HAND GRIP ADJUSTMENT HOLES AND AT THE ARMPAD CONNECTION ON THE OPPOSITE WING TUBE. THE CRUTCH SHOWS VERY LITTLE SIGN OF ANY OTHER DEFORMATION. THE SAMPLE SUGGESTS A SLOW FATIGUE FAILURE AT THE BREAKAGE POINT. THE ROOT CAUSE IS MOST LIKELY THE RESULT OF SHIPPING DAMAGE THAT WENT UNNOTICED BY THE END USER. CRACKED ARMPAD, POTENTIALLY CAUSED BY SHIPPING DAMAGE, INDUCED HIGHER LOAD TRANSFER TO THE AFFECTED WING TUBE, AND AFTER TIME THE INCREASED FATIGUE LOADING AND MOTION ALLOWED BY A WEAK ARMPAD CONNECTION LED THE TUBE TO BREAK AWAY FROM THE REST OF THE UNIT. A MANUFACTURING DEFECT COULD NOT BE DETERMINED IN THE MATERIAL OR WORKMANSHIP. HARDNESS OF THE UNIT MATERIAL WAS IN SPECIFICATION. NO TREND HAS BEEN ASSESSED FOR BREAKING TUBES.

    Description of Event or Problem · 1

    CRUTCH BROKE WHILE END USER WAS AMBULATING. HE FELL AND TORE HIS MCL. NO SURGICAL INTERVENTION WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUTCH, ALUMINUM, ADULT MEDIU NONE IPR MEDLINE INDUSTRIES, INC. MDSV80535 J090700269

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other