BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2920212 · Received December 17, 2012

    Report

    Report Number
    1811755-2012-04275
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WITHIN THE MOTOR WAS FOUND TO BE DAMAGED, WHICH IS PROBABLE CAUSE OF THE BIAS CURRENT ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR FACILITY, THE SAW CAUSED A BIAS CURRENT ERROR TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MFR FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW ERL STRYKER INSTRUMENTS, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK