BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2082671 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01453
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS DUPLICATED. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE TO THE MOTOR, ROTOR, BEARINGS, PRESS PLUG AND OTHER COMPONENT PARTS. 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 REPAIR BECAUSE IT WAS OVERHEATING DURING A PROCEDURE. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT; THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    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