BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL DISPOSABLE PACK BONE-TENDON-BONE

    MDR report key: 5429091 · Received February 10, 2016

    Report

    Report Number
    0002936485-2016-00139
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    November 17, 2015
    Report Date
    November 18, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. VISUAL INSPECTION: TIP DEFORMATION OBSERVED. PIECES OF THE TIP HAVE CHIPPED OFF AS WELL. THE TIP PIECES WERE NOT RECEIVED WITH THE DEVICE. THE PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD BE DUE TO EXCESSIVE FORCE APPLIED BY USER TO DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HLE DRILLING THE TIBIAL GUIDE PIN, IT WAS NOTED THAT THE DRILL BIT END OF THE OF THE PIN WAS BENT AS IT EXITED AT THE TIBIAL PLATEAU. SURGEON NOTED THAT THE PIN HIT NEITHER THE TIBIAL ARM NOR THE TOP OF THE NOTCH. WHILE DRILLING, THERE WAS NO FEEDBACK THAT FELT UNUSUAL. THE FEMORAL TUNNEL WAS DRILLED WITH A SEPARATE PIN. GUIDE PIN WAS REMOVED AFTER THE TIBIAL TUNNEL WAS REAMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85371 ACL DISPOSABLE PACK BONE-TENDON-BONE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE. KDD STRYKER ENDOSCOPY-SAN JOSE 15211AG2

    Patients

    Seq Age Sex Outcome Treatment
    1