BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP DISTAL TIBIA T-PLATE 5 HOLES/90MM

    MDR report key: 4449842 · Received January 26, 2015

    Report

    Report Number
    3003506883-2015-10029
    Event Type
    Injury
    Date Received
    January 26, 2015
    Report Date
    January 14, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK080522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S MEDICAL RECORD NUMBER: (B)(4). EVENT DATE: UNKNOWN. IT IS UNKNOWN IF THE COMPLAINANT PART WILL BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURE DATE: JUNE 10, 2013. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DISTAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH ONE NON-CONFORMANCE NOTED. NON-CONFORMANCE REPORT (NCR) # (B)(4) WAS GENERATED DUE TO FEATURE PDH BEING UNDERSIZED. ONE (1) PART WAS SCRAPPED PER NCR (B)(4). THIS LOT 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 WITH ONE NON-CONFORMANCE REPORT NOTED. NCR (B)(4) WAS WRITTEN DUE TO THE CERTIFICATE OF TESTING HAVING NO REVISION LEVEL LISTED AND A MISSING CONDITION CODE. EIGHT POUNDS OF THE RAW MATERIAL WAS SCRAPPED AND RETURNED TO SUPPLIER FOR RECERTIFICATION AND THE REMAINING (B)(4) WERE DISPOSITIONED AS ¿USE AS IS.¿ THE CONDITION CODE WAS NOT A REQUIREMENT ON THE CERTIFICATE OF TESTING AT THAT TIME. THIS RAW MATERIAL LOT 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. DEVICE 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 HARDWARE FAILURE OF A RIGHT PILON FRACTURE AND A NON-UNION OF A COMMINUTED PILON DISTAL TIBIA WITH AN ASSOCIATED COMMINUTED THREE PART DISTAL FIBULA NON-UNION FRACTURE WAS DISCOVERED POSTOPERATIVELY. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 AND SUBSEQUENTLY EXPERIENCED NON-UNION. ON (B)(6) 2015, THE FOLLOWING WERE EXPLANTED: A BROKEN FIVE-HOLE LOCKING COMPRESSION PLATE DISTAL TIBIA T-PLATE IMPLANTED POSTERIORLY (NONE OF SCREWS WERE BROKEN: TWO DISTAL 3.5 MILLIMETER (MM) LOCKING AND TWO PROXIMAL 3.5 MM CORTEX) AND A SIX-HOLE VARIABLE ANGLE LOCKING COMPRESSION PLATE TO THE MEDIAL DISTAL TIBIA (NOT BROKEN), TWO PROXIMAL 3.5 MM CORTEX SCREWS (NOT BROKEN), AND TWO OF THREE 2.7 MM VARIABLE ANGLE SCREWS, WHICH HAD BROKEN DISTALLY. A TEMPORARY EX-FIX WAS UTILIZED AND CULTURES WERE TAKEN FOR POSSIBLE INFECTION. FUTURE TREATMENT PLAN INCLUDES AN ANKLE ARTHRODESIS NAIL. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59236 3.5MM LCP DISTAL TIBIA T-PLATE 5 HOLES/90MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7328083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention