BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA PLATE 2 LEVEL/36MM

    MDR report key: 2841398 · Received October 23, 2012

    Report

    Report Number
    8030965-2012-01104
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. VISIBLE INVESTIGATION SHOWS THAT THE PLATE WAS BENT BY THE USER; ONE CLIP IS DAMAGED AND THE OTHER CLIPS SHOW WEAR AND MARKS OF USE. DUE TO THE DAMAGE AND THE FACT THAT THE PLATE WAS BENT IT IS NOT POSSIBLE TO CHECK THE RELEVANT POST-MANUFACTURING SPECIFICATIONS. THE DEVICE HISTORY RECORDS REVIEW SHOW THAT THE PLATE MET THE SPECIFICATIONS AFTER MANUFACTURING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND REVIEWED; NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE MANUFACTURING EVALUATION IS REPORTED AS THE FOLLOWING: DUE TO THE DAMAGE AND THE FACT THAT THE PLATE WAS BENT IT IS NOT POSSIBLE ANYMORE TO CHECK THE RELEVANT POST-MANUFACTURING SPECIFICATIONS. THE DHR RECORDS SHOW THAT THE PLATE MET TO THE SPECIFICATIONS AFTER MANUFACTURING. THE PRODUCT DEVELOPMENT EVENT EVALUATION IS REPORTED AS THE FOLLOWING: THERE IS NO EVIDENCE TO SUGGEST THE DESIGN OF THE DEVICE PLAYED A ROLE IN THE COMPLAINT MENTIONED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING A PROCEDURE, SURGEON WAS USING THE PLATE BENDER ON THE VECTRA AND HE HEARD A CRACK. SURGEON THOUGHT THE INTEGRITY OF THE PLATE WAS IN QUESTION DUE TO THE CRACK SOUND AND DID NOT WANT TO USE IT IN THE PROCEDURE. THE SECOND PLATE WAS USED IN THE PT ALL THE SCREWS WERE IN PLACE. THE SURGEON DID NOT FEEL THE PLATE WAS IN AN OPTIMAL POSITION AND DECIDED TO REMOVE THE PLATE AND REPOSITION IT. UPON REMOVAL OF THE PLATE, THE SILVER BLOCKING CLIP BROKE OFF. THE PARTS WERE RETRIEVED FROM THE PT. THIS CAUSED A TEN MINUTE DELAY, THERE WAS NO ADVERSE EFFECT NOTED TO THE PT. THE PLATE IN THIS COMPLAINT WAS IMPLANTED AND THEN REMOVED. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI VECTRA PLATE 2 LEVEL/36MM VECTRA PLATE KWQ SYNTHES GMBH 7507982

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PLATE| SCREW