BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION CARTG(18.3X1.33X105)

    MDR report key: 3890154 · Received June 24, 2014

    Report

    Report Number
    0001811755-2014-02248
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE FAILURE WAS CONFIRMED. INFORMATION PROVIDED BY THE ACCOUNT SUGGESTED THAT AN ISSUE WAS OBSERVED IN RELATION TO THE HANDPIECE DURING THIS EVENT THAT POTENTIALLY CONTRIBUTED TO THE REPORTED EVENT. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE BLADE BROKE AT THE MOUNT. THE BLADE WAS CHANGED BUT THE HANDPIECE WAS THEN ALSO FOUND TO BE BROKEN. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS FURTHER REPORTED THAT AN X-RAY WAS PERFORMED TO ENSURE A PIECE WAS NOT LEFT IN THE PATIENT AND THERE WAS A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE BLADE BROKE AT THE MOUNT. THE BLADE WAS CHANGED BUT THE HANDPIECE WAS THEN ALSO FOUND TO BE BROKEN. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS FURTHER REPORTED THAT AN X-RAY WAS PERFORMED TO ENSURE A PIECE WAS NOT LEFT IN THE PATIENT AND THERE WAS A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367713 PRECISION CARTG(18.3X1.33X105) BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) LOT 1120302323| (B)(4) LOT