BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDE HALO RADIOLUCENT RETRACTOR

    MDR report key: 1675905 · Received April 23, 2010

    Report

    Report Number
    3004608878-2009-00120
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    December 7, 2010
    Report Date
    April 23, 2010
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFE SCIENCE ENGINEERS HAVE COMPLETED A THOROUGH INVESTIGATION AND EVALUATION ON THE RETURNED UNIT AND FOUND THE FOLLOWING: THE SNAKE RETRACTOR INNER SLIDE THREADS WERE FOUND TO BE DAMAGED AND, IN ONE CASE, BROKEN. THIS IS CONSISTENT WITH OVER TIGHTENING THE INNER SLIDE MECHANISM. SEVERAL RETRACTOR BLADES WERE FOUND TO BE BADLY DEFORMED AND REQUIRED REPLACING. THE ROD SUPPORT CLAMP SIDE CASTING WAS FOUND TO BE BROKEN. THE ROOT CAUSE OF THE MATERIAL BREAKAGE COULD NOT BE IDENTIFIED; HOWEVER, THE BREAKAGE IS CONSISTENT WITH OVERPRESSURE ON THE CASTING, CAUSING THE MATERIAL TO BREAK ON THE HIGHEST PRESSURE POINT - THE RIGHT ANGLE. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FURTHER INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THIS IS THE SECOND INCIDENT INVOLVING A BUDDE HALO RADIOLUCENT RETRACTOR SYSTEM FROM THE SAME FACILITY THAT WAS INVOLVED IN AN INCIDENT DURING A PROCEDURE IN (B)(6). (CROSS REFERENCE WITH MDR # 3004608878-2009-00108). THE INCIDENT WAS DESCRIBED AS FOLLOWS: THE ROD SUPPORT CLAMP ASSEMBLY BROKE WHEN SCREWING IT. ALTHOUGH THERE WAS NO PT CONTACT OR PT INJURY INVOLVED, THERE WAS A SIGNIFICANT DELAY IN SURGERY OF 30 MINUTES WHILE ANOTHER UNIT WAS SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUDDE HALO RADIOLUCENT RETRACTOR NONE GAD

    Patients

    Seq Age Sex Outcome Treatment
    1