BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 2071615 · Received March 28, 2011

    Report

    Report Number
    1811755-2011-00974
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED. ACCORDING TO THE INVESTIGATION DETAILS THE RUBBER SEAL NEEDED TO BE REPLACED. THE DEVICE WAS REPAIRED/REPLACED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH: IT WAS REPORTED THAT DURING A PHALANX REMOVAL PROCEDURE, WHEN THE SAW WAS ACTIVATED AND WHEN THE TRIGGER WAS PULLED, INSTRUMENT LUBRICANT AND SMALL DARK PIECES OF MATTER CAME OUT OF THE HEAD OF THE INSTRUMENT. THE CUSTOMER DESCRIBED THE PARTICULATE DEBRIS TO BE BITS OF THE RUBBER RING THAT DETERIORATED AND ALLOWED LUBRICANT TO SEEP. THE PT'S WOUND WAS IRRIGATED AND THE PT WAS PROVIDED AN ANTIBIOTIC WHILE IN THE OPERATING ROOM. RISK MANAGEMENT AT THE ACCOUNT HAS CONTINUED TO FOLLOW-UP WITH THE PT AND THERE ARE NO ADVERSE CONSEQUENCES AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention