BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ANKLE CLAMP ASSEMBLY

    MDR report key: 3870646 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02272
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SEIZED SCREW INVOLVING A TIBIAL ANKLE CLAMP ASSEMBLY WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE NO PATIENT DEMOGRAPHICS OR MEDICAL RECORDS WERE PROVIDED. IT IS NOT BELIEVED THAT PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONCLUDED THAT THERE HAS BEEN 1 OTHER EVENT FOR THE LOT REFERENCED. PREVIOUS INVESTIGATION INDICATED THAT THERE WAS SIGNIFICANT DAMAGE ON THE SHAFT OF THE BROKEN PROXIMAL LOCKING SCREW, WHICH SUGGESTED THAT THE KNOB BROKE OFF DUE TO AN EXCESSIVE AMOUNT OF APPLIED FORCE. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE ADJUSTMENT SCREW WAS SEIZED INSIDE THE SLIDE COMPONENT, LIKELY CAUSED BY ITS OVER-ROTATION BEYOND THE DESIGNED LIMIT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE SCREW FOR LATERAL ADJUSTMENT COULD NOT BE FIXATE. THE SURGERY COULD BE FINISHED WITH A SECOND DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE SCREW FOR LATERAL ADJUSTMENT COULD NOT BE FIXATE. THE SURGERY COULD BE FINISHED WITH A SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347859 TIBIAL ANKLE CLAMP ASSEMBLY INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH RD2T020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other