BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL TIBIA PLATE8 HOLES/154MM-LEFT

    MDR report key: 2883486 · Received December 21, 2012

    Report

    Report Number
    3003506883-2012-00406
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K011978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    SURGERY TO REMOVE A 4.5 LCP TIBIA PLATE DUE TO NON UNION WAS PERFORMED ON (B)(6) 2012. THE PLATE WAS REPLACED WITH A 3.5 LCP MEDIAL PROXIMAL TIBIA PLATE TO REVISE THE FRACTURE. THE HARDWARE WAS REPORTED TO BE INTACT. WHILE THE SURGEON WAS PLACING A 3.7MM CANNULATED LOCKING SCREW INTO THE 3.5 LCP MEDIAL PROXIMAL TIBIA PLATE, THE CANNULATED, STARDRIVE SCREWDRIVER BECAME DEFORMED AS HE WAS SEATING THE SCREW. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITHOUT A NEGATIVE EFFECT ON THE OUTCOME OF THE CASE.

    Description of Event or Problem · 1

    THE PATIENT WAS STATUS POST ORIF, DATE NOT SPECIFIED, AND DEVELOPED A VARUS NON UNION OF THE LEFT TIBIA MORE THAN SIX MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP PROXIMAL TIBIA PLATE8 HOLES/154MM-LEFT 4.5MM LCP PROXIMAL TIBIA PLATE HRS SYNTHES ELMIRA 6204801

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention