BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABO SAG SAW

    MDR report key: 3133435 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01225
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE TIP PIECE FALLING OFF WAS CONFIRMED. SIGNS OF THIRD PARTY WORK ON VARIOUS COMPONENTS OF THE DEVICE WERE NOTED DURING FAILURE ANALYSIS. UNAUTHORIZED MODIFICATION OF THESE COMPONENTS IS A PROBABLE CAUSE OF THE REPORTED DISASSEMBLY. THE DEVICE INSTRUCTIONS FOR USE STATE THAT THE DEVICE SHOULD NOT BE DISASSEMBLED OR ATTEMPTED TO BE SERVICED, AND THAT NO SYSTEM COMPONENTS OR ACCESSORIES SHOULD BE MODIFIED. THE INSTRUCTIONS FOR USE FURTHER STATE THAT ALL CONCERNS SHOULD BE DIRECTED TO STRYKER CUSTOMER SERVICE. STRYKER RECOMMENDS THAT ALL FAILURES AND MAINTENANCE ASSOCIATED WITH ITS DEVICES SHOULD BE DIRECTED TO TRAINED STRYKER SERVICE PROFESSIONALS.

    Additional Manufacturer Narrative · 1

    (B)(4): FAILURE ANALYSIS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SURGICAL PROCEDURE AT THE USER FACILITY THE TIP FELL OFF THE SAGITTAL HEAD OF THE DEVICE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. THE USER FACILITY REPORTED PREVIOUS THIRD PARTY REPAIR, WHICH WAS CONFIRMED UPON EVALUATION AT THE MANUFACTURER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A SURGICAL PROCEDURE AT THE USER FACILITY THE TIP FELL OFF THE SAGITTAL HEAD OF THE DEVICE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. THE USER FACILITY REPORTED PREVIOUS THIRD PARTY REPAIR, WHICH WAS CONFIRMED UPON EVALUATION AT THE MANUFACTURER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234223 SABO SAG SAW ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1