BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP CONDYL-PL 4.5/5 CURV R 12HO L278 SST

    MDR report key: 3241442 · Received July 22, 2013

    Report

    Report Number
    3003506883-2013-00320
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ADDITIONAL EVALUATION REPORTS AS RECEIVED CONDITIONS TO BE THE LCP CONDYLAR PLATE WAS BENT POST-OP. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED. THE MANUFACTURING EVALUATION REPORTS AS RECEIVED CONDITIONS TO BE AS THE PART WAS RECEIVED AND UPON VISUAL INSPECTION FOUND NUMEROUS SURFACE SCRATCHES MAINLY ON THE TOP SURFACE OF THE PLATE. ADDITIONALLY THERE WAS DISCOLORATION IN BALL HOLES 7 AND 9 WITH A DEEP GOUGE IN HOLE 8. THE BEND NOTED IN THE COMPLAINT OCCURRED IN THE THREADED PORTION OF HOLE 5. INSPECTION PERFORMED DURING THIS EVALUATION AGAINST THE REQUIREMENTS AT THE TIME THE PART WAS RELEASED FOUND NOTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS DEEMED INDETERMINATE

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED ON 06/11/2013. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM CURVED CONDYLAR PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) WHO IS REPORTING AN EVENT IN (B)(6) AS FOLLOWS: A LOCKING COMPRESSION PLATE , LCP, CONDYLAR PLATE BENT POST OPERATIVELY. PATIENT FELL ON (B)(6) 2013 AND WAS TREATED FOR A RIGHT FEMORAL FRACTURE WITH OSTEOSYNTHESIS ON (B)(6) 2013 WITH THE LCP CONDYLAR FEMUR PLATE. THE POST OP X-RAYS WERE FINE AND PATIENT WAS TRANSFERRED TO A GERIATRIC WARD. ON (B)(6) 2013 THE X-RAY CONTROL SHOWED THAT THE PLATE IS BENT. THE FOLLOWING INFORMATION WAS RECEIVED FROM THE KNEE SURGEON, THE PATIENT WILL RECEIVE A JOURNEY ACTIVE KNEE PROSTHESIS. RETROGRADE NAILING IS IMPOSSIBLE. MATERIAL WAS RECEIVED ON (B)(6) 2013 AND A REQUEST HAS BEEN MADE TO CLARIFY THE SURGERY DATE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340755 LCP CONDYL-PL 4.5/5 CURV R 12HO L278 SST KTT SYNTHES ELMIRA 6991200

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention