BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE DOUBLE ANGLERECON PL MEDIUM 2.5MM THICK

    MDR report key: 3082115 · Received April 29, 2013

    Report

    Report Number
    3003506883-2013-10148
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION: PRODUCT DEVELOPMENT EVALUATION SHOWED ONE MEDIUM 2.5MM THICK MATRIXMANDIBLE DOUBLE ANGLE RECONSTRUCTION PLATE (P/N 04.503.742) WAS RETURNED IN TWO PIECES. THE PLATE IS BROKEN BETWEEN THE 9TH AND 10TH HOLE ON THE PATIENT¿S LEFT SIDE. THE 9TH AND 10TH SCREW HOLES ARE WARPED AND THERE ARE SOME MINOR SCRATCHES AS WELL AS SOME DEEPER GOUGES IN THE REGION OF THE BREAKAGE. THESE MARKS ARE CONSISTENT WITH PLATE BENDING. THE PLATE IS CUT IN TWO LOCATIONS; TO THE RIGHT OF THE 14TH HOLE ON THE PATIENT¿S RIGHT SIDE, AND TO THE LEFT OF THE 12TH HOLE ON THE PATIENT¿S LEFT SIDE. AS NOTED IN THE COMPLAINT DESCRIPTION, THE MATRIXMANDIBLE PLATE BROKE DURING BENDING. MECHANICAL TESTING WAS PREVIOUSLY PERFORMED TO ENSURE ADEQUATE STRENGTH OF THE PLATES. THE DEEP GOUGES AND DEFORMED SCREW HOLES ADJACENT TO THE FRACTURE SUGGEST THAT THE PLATE MAY HAVE UNDERGONE EXTENSIVE OR REVERSE BENDING IN THIS REGION. THE MATRIXMANDIBLE TECHNIQUE GUIDE ((B)(4)) CAUTIONS AGAINST REVERSE BENDS AND SHARP BENDS AS THESE COULD WEAKEN THE PLATE AND LEAD TO PREMATURE PLATE FAILURE. WHILE REVERSE BENDING IS THE LIKELY CAUSE OF PLATE FAILURE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE EXACT CAUSE, SO THIS COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE. THIS COMPLAINT IS INDETERMINATE FROM A DESIGN PERSPECTIVE BECAUSE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE EXACT CAUSE OF FAILURE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE TI MATRIXMANDIBLE DOUBLE ANGLE RECON PLATE, MEDIUM 2.5MM THICK WAS RECEIVED IN TWO PIECES. THIS DEVICE IS MANUFACTURED AS A 5 HOLE X 22 HOLE X 5 HOLE DOUBLE ANGLE PLATE. HOWEVER, WHEN FITTING THE TWO RECEIVED PIECES TOGETHER AT THE DETERMINED FRACTURE LOCATION, IT IS EVIDENT THAT PIECES ARE MISSING FROM EACH END OF THE PLATE. THE TWO RECEIVED PIECES OF THE CONSTRUCT WERE FRACTURED BETWEEN THE #20 AND #21 HOLE AREA, NEAR THE RIGHT END (LASER MARK SIDE UP) OF THE MIDDLE SECTION (22 HOLES SECTION) OF THE PLATE. IT WAS OBSERVED THAT A 2ND FRACTURE OCCURRED BETWEEN THE #1 AND #2 HOLES IN THE BEND AREA (5 HOLES SECTION) AT THE RIGHT END OF THE PLATE (PIECE NOT RECEIVED). IT WAS ALSO OBSERVED THAT A 3RD FRACTURE OCCURRED BETWEEN THE #3 AND #4 HOLES IN THE BEND AREA (5 HOLES SECTION) AT THE LEFT END OF THE PLATE (PIECE NOT RECEIVED). THE MAIN PLATE SECTION (LARGE PIECE) WAS RECEIVED BENT IN A U SHAPE. IT WAS ALSO OBSERVED THAT BOTH PIECES HAD MULTIPLE SURFACE SCRATCHES. THE BEND AREA SECTION (SMALL PIECE) HAD A GOUGE WITH THE ANODIZE FINISH REMOVED. IN CONCLUSION, THE RECEIVED DEVICE WAS INSPECTED FOR ALL PERTINENT FEATURES NEAR THE DEVICE FRACTURE AREA, AND ALL DIMENSIONS RELEVANT TO THIS COMPLAINT CONDITION WERE WITHIN SPECIFICATION. BASED UPON THE FACT THAT ALL PERTINENT DIMENSIONS WERE WITHIN SPECIFICATION, AND NO ANOMALIES WERE IDENTIFIED IN THE DEVICE HISTORY RECORD AND RAW MATERIAL DEVICE HISTORY RECORD THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION, THIS COMPLAINT AGAINST THIS TI MATRIXMANDIBLE DOUBLE ANGLE RECON PLATE-MEDIUM-2.5MM THICK IS DEEMED INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBLE RECONSTRUCTION WITH RIB GRAFT, THE PLATE BROKE WHILE SURGEON WAS ATTEMPTING TO BEND IT IN SITU. THE PLATE WAS REMOVED AND WAS REPLACED WITH A NEW PLATE. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEM. EVENT #1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184515 TI MATRIXMANDIBLE DOUBLE ANGLERECON PL MEDIUM 2.5MM THICK JEY SYNTHES ELMIRA 6011058

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR