BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ALIGNMENT HANDLE

    MDR report key: 3970186 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02915
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISASSEMBLY ISSUES INVOLVING A TIBIAL ALIGNMENT HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW. INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE REPORTED EVENT ALLEGES THAT IT WAS NO POSSIBLE TO DISCONNECT THE TIBIAL ALIGNMENT HANDLE FROM THE TIBIA TEMPLATE. THE TRIAL INSERT WAS ON TOP OF THE BASEPLATE TRIAL AND IT IS REPORTED THAT THE ALIGNMENT HANDLE MADE CONTACT WITH THE TRIAL INSERT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. IN ORDER TO COMPLETE A FULL INVESTIGATION THE DEVICE AS WELL AS THE TIBIAL TEMPLATE AND TRIAL INSERT WOULD NEED TO BE RETURNED TO DETERMINE THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE AREA SALES REPRESENTATIVE, THAT DURING THE TRIAL ASSESSMENT IT WAS ALLEGEDLY NOT POSSIBLE TO DISCONNECT THE TIBIAL ALIGNMENT HANDLE FROM THE TRIATHLON TIBIA TEMPLATE WITH THE TRIATHLON CS INS SIZE 1 / 9MM ON TOP OF IT. THE CUSTOMER REPORTED THAT THE TIBIAL ALIGNMENT HANDLE MADE CONTACT WITH THE TRIAL INSERT. THE CUSTOMER REPORTED THAT THE THE PROCEDURE WAS COMPLETED WITHOUT THE TIBIAL ALIGNMENT HANDLE. THE CUSTOMER HAS PROVIDED IMAGES OF THE DEVICE. PLEASE SEE ATTACHMENTS IN THE COMMUNICATION LOG.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE AREA SALES REPRESENTATIVE, THAT DURING THE TRIAL ASSESSMENT IT WAS ALLEGEDLY NOT POSSIBLE TO DISCONNECT THE TIBIAL ALIGNMENT HANDLE FROM THE TRIATHLON TIBIA TEMPLATE WITH THE TRIATHLON CS INS SIZE 1 / 9MM ON TOP OF IT. THE CUSTOMER REPORTED THAT THE TIBIAL ALIGNMENT HANDLE MADE CONTACT WITH THE TRIAL INSERT. THE CUSTOMER REPORTED THAT THE THE PROCEDURE WAS COMPLETED WITHOUT THE TIBIAL ALIGNMENT HANDLE. THE CUSTOMER HAS PROVIDED IMAGES OF THE DEVICE. PLEASE SEE ATTACHMENTS IN THE COMMUNICATION LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448377 TIBIAL ALIGNMENT HANDLE INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N3V74

    Patients

    Seq Age Sex Outcome Treatment
    1 Other