BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION REAMER ASSEMBLY. OMEGA PLUS TI

    MDR report key: 3200908 · Received July 2, 2013

    Report

    Report Number
    0008031020-2013-00216
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT SEVERAL USAGE MARKS ARE VISIBLE ON THE WHOLE ITEM (SCRATCHES AT THE AO COUPLING AND DEFORMATIONS OF THE COMBO REAMER DRILL TIP. THERE ARE TWO POSSIBLE REASONS FOR THE REPORTED FAILURE MODE: FIRST, IT COULD BE ASSUMED THAT THE BARREL REAMER ASSEMBLY WAS FIXED IN THE WRONG POSITION. DUE TO THAT IT WAS REAMED FURTHER THAN INTENDED. SECOND, IT COULD BE ASSUMED THAT THE FIXATION OF THE BARREL REAMER ASSEMBLY WAS NOT PERFORMED CORRECTLY AND DUE TO THIS ISSUE, THE BARREL REAMER ASSEMBLY SLIPPED TO ANOTHER POSITION AND THE SHAFT WAS REAMED FURTHER THAN INTENDED. AFTER THE BML TEST WAS PERFORMED, AN ADDITIONAL TEST UNDER CONTROLLED CONDITIONS WAS RUN TO ANALYZE THE FIXATION STRENGTH OF THE BARREL REAMER ASSEMBLY ONTO THE COMBO REAMER DRILL. PLEASE NOTE THAT THE TEST RESULTS OF THE TWO TESTED OMEGA COMBINATION REAMER ASSEMBLIES SHOWED NO RELATIVE DISPLACEMENT UP TO 5KN LOADING. THE ACCEPTANCE CRITERIA WAS MET. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS AND A PREVIOUS SIMILAR CASE, THIS CASE COULD BE CLASSIFIED AS USER RELATED.

    Description of Event or Problem · 1

    DURING OMEGA CHS SURGERY, THE SURGEON USED THE COMBINATION REAMER. IN REAMING, THE LOCKING PART OF THE COMBINATION REAMER LOOSENED.

    Description of Event or Problem · 1

    DURING OMEGA CHS SURGERY, THE SURGEON USED THE COMBINATION REAMER. IN REAMING, THE LOCKING PART OF THE COMBINATION REAMER LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301631 COMBINATION REAMER ASSEMBLY. OMEGA PLUS TI INSTRUMENT LXH STRYKER TRAUMA SELZACH G04785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other