BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CURVED BROAD LCP® PLATE 14 HOLES/265MM

    MDR report key: 4223361 · Received November 4, 2014

    Report

    Report Number
    3009450884-2014-10081
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE (B)(4) IS MENTIONED IN THE MANUFACTURING DOCUMENT, INDICATING "SUPERFICIAL DEPRESSIONS ON THE UPPER SIDE". SUBSEQUENTLY, THE PARTS WERE REWORKED (HONED) AND THE PRODUCT QUALITY WAS ASSESSED AS EQUIVALENT TO MATERIAL MANUFACTURED WITHOUT REWORK. THUS IT CAN BE CONCLUDED THAT REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL MANUFACTURE DATE: NOVEMBER 13, 2013. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE PLATE WAS RECEIVED AS COMPLAINED IN TWO PIECES. THE PRODUCT DRAWING WAS REVIEWED DURING THIS EVALUATION. NO DRAWING DISCREPANCIES WERE IDENTIFIED. THIS PLATE FAILED UNDER FATIGUE RELATED TO INSUFFICIENT BONE HEALING. THE COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TREATED ON AN UNKNOWN DATE APPROXIMATELY FIVE MONTHS AGO FOR A PERIPROSTHETIC FRACTURE, AND WAS INSTRUMENTED WITH SYNTHES HARDWARE. THE PATIENT WAS REPORTEDLY NON-WEIGHT BEARING UNTIL 1 WEEK AGO. UPON ALLOWING THE PATIENT TO BEAR WEIGHT ON THE LEG WITHIN THE LAST WEEK, THE SURGEON REPORTED THAT THE PLATE BROKE WHERE THE ORIGINAL FRACTURE WAS LOCATED. BROKEN HARDWARE WAS REMOVED ON (B)(6), 2014. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707246 4.5MM CURVED BROAD LCP® PLATE 14 HOLES/265MM PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 8709767

    Patients

    Seq Age Sex Outcome Treatment
    1