BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3140595 · Received May 31, 2013

    Report

    Report Number
    0001811755-2013-01268
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION A CRACKED YOKE WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MICRO SAGITTAL SAW WILL NOT HOLD BLADES. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND THAT THE DEVICE HAD SEVERE BLADE WHIP WHICH WOULD LOOK LIKE THE BLADE WAS NOT LOCKED IN ALL THE WAY. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO THE USER REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MICRO SAGITTAL SAW WILL NOT HOLD BLADES. UPON EVALUATION AT THE MANUFACTURER IT WAS FOUND THAT THE DEVICE HAD SEVERE BLADE WHIP WHICH WOULD LOOK LIKE THE BLADE WAS NOT LOCKED IN ALL THE WAY. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO THE USER REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240999 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1