BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 2981401 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00803
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). THE REPORT CONCLUDED THAT THE JAWS OF THE CABLE TENSIONERS WERE CORRODING. THE INTERNAL SURFACES EXHIBITED SIGNIFICANT AMOUNTS OF IRON OXIDE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. A FURTHER VISUAL ANALYSIS NOTED THAT IMPRINTED ON THE HANDLE OF THE DEVICE WAS THE WARNING "CLEAN AND LUBE AFTER EACH USE". THE EVENT WAS CONFIRMED. THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS MANUFACTURING LOT. THE INVESTIGATION CONCLUDED THAT THE INABILITY OF THE DALL MILES CABLE TENSIONER TO GRASP THE CABLE WAS CAUSED BY CORROSION. A MATERIAL ANALYSIS REPORT CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE TENSIONERS WOULD NOT LOCK ONTO THE CABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE TENSIONERS WOULD NOT LOCK ONTO THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85428 D/M ONE-SIDED CABLE TENSIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other