BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL TIBIA PL 18 HOLES/334MM RT-STE

    MDR report key: 2649923 · Received June 28, 2012

    Report

    Report Number
    3003506883-2012-00161
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JWH
    PMA / PMN Number
    K052390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PT TREATED WITH ORIF FOR RIGHT TIBIAL PLATEAU FRACTURE WITH SHAFT EXTENSION, RETURNED TO SURGEON FOR FOLLOW-UP. CLINICAL EXAM REVEALED PROBABLE NON-UNION. PT WAS RETURNED TO OPERATING ROOM FOR REVISION ON (B)(6) 2012. SURGEON FOUND THE TIBIAL PLATEAU FRACTURE WAS HEALED, BUT THE DISTAL TIBIA WAS NOT HEALED. SURGEON REMOVED 1 PLATE (240.052S) AND AN UNK NUMBER OF ASSORTED SCREWS. AS THE SURGEON WAS COMPLETING REAMING, HE PULLED THE REAMER BACK TO REMOVE IT. THE REAMER BECAME STUCK AT THE NON-UNION CALLUS POINT. SURGEON PULLED HARD ON THE REAMER SHAFT, AND THE PLASTIC TUBE BROKE. ALL PIECES OF THE REAMER TUBE WERE RETRIEVED. DR WAS THEN ABLE TO IMPLANT A TIBIAL NAIL AND SCREWS AND AUTOGRAFT WITH NO FURTHER PROBLEM. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL TIBIA PL 18 HOLES/334MM RT-STE PROXIMAL TIBIA PL JWH SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention PLATE| SCREW| PLATE| SCREW