BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2090672 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01299
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED; LEAKING WAS NOT NOTED. UPON DISASSEMBLY OF THE DEVICE, IT WAS NOTED THAT THE BEARINGS, DRIVESHAFT AND OTHER COMPONENT PARTS WERE CORRODED. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE STRYKER MICRO RECIPROCATING SAW WAS SENT IN FOR EVAL BECAUSE IT WAS LEAKING OIL DURING A PROCEDURE. THERE WAS NO LEAK OR DROP AT THE SURGICAL SITE. NO ADVERSE EVENT WAS REPORTED, NO IRRIGATION WAS DONE AND NO MEDICAL TREATMENT WAS PROVIDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROCEDURE DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK