BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOKWALTER TILT RATCH MECH

    MDR report key: 1706617 · Received May 17, 2010

    Report

    Report Number
    1226348-2010-00153
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Report Date
    April 20, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FFO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE SPRING THAT SHOULD HAVE BEEN SWAGED AND FOUND AT THE THUMB SCREW AREA OF THE DEVICE WAS MISSING. IT IS NOT POSSIBLE TO DETERMINE HOW THE SPRING BECAME DETACHED, HOWEVER, IT COULD BE LIKELY THAT FREQUENT USE AND STERILIZATION OVER A PROLONGED PERIOD RESULTED IN SPRING DETACHMENT. THIS INSTRUMENT IS (B)(6) OLD AND DEMONSTRATES EXCESSIVE WEAR THROUGHOUT THE METAL SURFACES. ALTHOUGH EXCESSIVE WEAR WAS FOUND, METALLURGIC DEFECTS SUCH AS CORROSION WERE NOT FOUND. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RATCHET SPRING POPPED OUT DURING SURGERY. THE SPRING COULD NOT BE LOCATED, BUT X-RAYS WERE TAKEN TO ENSURE THE COMPONENT WAS NOT LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOKWALTER TILT RATCH MECH RETRACTOR, SELF RETAINING FFO CODMAN & SHURTLEFF, INC. NA 0402N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA