BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXOR RETRACTOR

    MDR report key: 2516789 · Received March 30, 2012

    Report

    Report Number
    9617544-2012-00116
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    July 6, 2011
    Report Date
    July 10, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    GAD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: VISUAL INSPECTION: BOTH BASE PLATES HAD SIGNS OF MECHANICAL WEAR AND WERE OBSERVED TO BE DISASSEMBLING FROM THE DEVICE. MANUFACTURING RECORD REVIEW: THE DHR FROM BATCH 093309 WAS REVIEWED BUT NO INCIDENT THAT COULD EXPLAIN THE FAILURE WAS REPORTED. COMPLAINT HISTORY ANALYSIS: 3 PREVIOUS SIMILAR RECORDS HAVE BEEN RECEIVED ALL FROM BATCH 093309. THE RETURNED LUXOR RETRACTORS WERE FOUND TO HAVE OUT OF SPECIFICATION DOWEL PIN HOLES DIAMETERS. A CAPA WAS INITIATED TO ADDRESS THIS ISSUE. RISK ASSESSMENT: THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE TRADITIONAL APPROACH. CONCLUSIONS: THE DEVICE FAILURE DIRECTLY CAUSED THIS EVENT. THE DIAMETERS OF THE DOWEL PIN HOLES ON THE RETURNED DEVICE WERE ALSO FOUND TO BE OUT OF SPECIFICATION. ONE OF ACTIONS OF THE IMPLEMENTED CAPA TO PREVENT REOCCURRENCE IS A UNIT BY UNIT CONTROL OF THE DIAMETERS OF THE BASE PLATE HOLES WITH A GO/NO-GO GAUGE FOLLOWING SURFACE TREATMENT AND JUST PRIOR TO ASSEMBLY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR, (B)(6) HAS REPORTED THAT AFTER DISTRACTION OF THE BLADES INSIDE THE PATIENTS BODY, IT DID NOT GO BACK TO CLOSED POSITION AND TOOK A LOT OF TIME TO FIX IT. THE DISTRIBUTOR ALSO REPORTED THAT WHEN THE SURGEON STARTS TO DISTRACT THE BLADES AFTER 3-4 TURN, ONE IF THE BLADES DETACHES FROM THE RETRACTOR BASE. THE DISTRIBUTOR REPORTED THAT THE SURGEON STIMULATES THE FORCES ON THE BLADES OUT OF THE BODY WITH HIS HAND AND EVERYTHING WAS OK. THE DISTRIBUTOR HAS REPORTED THAT THE SURGEON TRIES THE SYSTEM 2-3 TIMES AND HE HAD THE SAME PROBLEM, THE SURGEON HAS TO PUT THE BLADES OFF AND GO FOR THE TRADITIONAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXOR RETRACTOR INSTRUMENT GAD STRYKER SPINE BORDEAUX NA 093309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention