BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXOR RETRACTOR

    MDR report key: 2556396 · Received April 27, 2012

    Report

    Report Number
    9617544-2012-00164
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    GAD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MFG 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 AND ONE OF THE DOWEL PINS (ON THE BLACK BASE PLATE) WAS CONFIRMED TO BE MISSING. MFG RECORD REVIEW: THE DHR FROM BATCH 093309 WAS REVIEWED BUT NO INCIDENT THAT COULD EXPLAIN THE FAILURE WAS REPORTED. COMPLAINT HISTORY ANALYSIS: 4 PREVIOUS SIMILAR RECORDS HAVE BEEN RECEIVED ALL FROM BATCH 093309. THE RETURNED LUXOR RETRACTORS WERE FOUND TO HAVE OUT OF SPEC DOWEL PIN HOLES DIAMETERS. A CAPA WAS INITIATED ON JUNE 16 2011 TO ADDRESS THIS ISSUE. RISK ASSESSMENT: NO ADVERSE CONSEQUENCE OR PT INVOLVEMENT WAS REPORTED IN THE SCOPE OF THIS COMPLAINT. CONCLUSION: 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 SPEC. 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

    IT WAS REPORTED THAT, "WHILE REVIEWING LOANER SET, FOUND INNER PIN OF THE RETRACTOR IS MISSING."

    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