BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP(TM) PL 18 HOLES/336MM-STERILE

    MDR report key: 2893232 · Received January 2, 2013

    Report

    Report Number
    8030965-2013-00003
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PLATE IS BROKEN IN HALF. THERE ARE SLIGHT SCRATCHES EVIDENT NEAR ALL OF THE HOLES ON THE PLATE. SOME RUST AND DISCOLORATION IS ALSO APPARENT ON MANY OF THE HOLES. IT IS ASSUMED BASED ON THE DRAWING 226.622 REV C THAT THIS PART WAS MANUFACTURED BY SYNTHES (B)(4). THE DHR REVIEW THAT WAS CONDUCTED INDICATED THAT THERE WERE NO COMPLAINT RELATED ISSUES DOCUMENTED WITH THIS LOT. THE INSTRUMENT CONFORMED TO SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE MATERIAL AND HARDNESS REQUIREMENTS ARE NOT SPECIFIED ON ANY DRAWING IN THE U.S. SYSTEM. THE ONLY REQUIREMENT ON THE DRAWING SPECIFIES THAT 226.682 SHOULD HAVE 18 HOLES. THIS WAS CONFIRMED. AN EXACT CAUSE FOR THIS COMPLAINT CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 4.5 MM CURVED BROAD LCP PLATE AND SCREWS ON (B)(6) 2012 FOR LEFT FEMUR SHAFT PERIPROSTHETIC FRACTURE FOLLOWING AN INJURY ON (B)(6) 2012. PATIENT REPORTEDLY FELL GETTING OUT OF THE BATHTUB. THE PATIENT FELT THE FEMUR SNAP GETTING OUT OF THE BATHROOM. PATIENT RETURNED TO THE SURGEON COMPLAINING OF SUDDEN ONSET OF PAIN FOLLOWING THE FALL. EXAM AND X-RAYS TAKEN ON AN UNKNOWN DATE REVEALED THE PLATE BROKE INTO TWO PIECES SIX WEEKS POST-OPERATIVELY ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE AND PATIENT WAS REVISED TO VA DISTAL FEMUR LOCKING PLATE CONSTRUCT WITH ILIAC CREST BONE GRAFT, FEMORAL ALLOGRAFT STRUT, AND DBX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853 4.5MM CURVED BROAD LCP(TM) PL 18 HOLES/336MM-STERILE 4.5MM CURVED BROAD LCP PLATE HRS SYNTHES GMBH 2716800

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention