BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO 2 SAG SAW

    MDR report key: 3173062 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01396
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED CHIPPED/BROKEN HEAD WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL INSPECTION. A SAGITTAL HEAD ASSEMBLY FAILURE, INVOLVING A CASTLE FEATURE ON LINK WITH FINS FAILURE, WAS THE LIKELY ROOT CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE SAGITTAL HEAD OF THE DEVICE WAS BROKEN/CHIPPED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT OF REPORTED DISASSEMBLY. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE SAGITTAL HEAD OF THE DEVICE WAS BROKEN/CHIPPED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT OF REPORTED DISASSEMBLY. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274649 SABO 2 SAG SAW EXEMPT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1