BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PLATE-20 HOLES

    MDR report key: 5547210 · Received April 5, 2016

    Report

    Report Number
    2520274-2016-11959
    Event Type
    Injury
    Date Received
    April 5, 2016
    Report Date
    March 18, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RETURNED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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.

    Additional Manufacturer Narrative · 1

    (LOT AND UDI NUMBERS), DEVICE AVAILABLE FOR EVALUATION?, DEVICE MANUFACTURE DATE. PRODUCT INVESTIGATION SUMMARY: THE OVERALL COMPLAINT CONDITION IS CONFIRMED AS ONE PLATE WAS RECEIVED BROKEN. LOT 6760952 WAS RECEIVED WITH THE FEMALE PLATE COMPONENT SHOWING A TRANSVERSE BREAK BETWEEN THE 3RD AND 4TH HOLE FROM MIDLINE AND THE MALE PLATE COMPONENT SHOWING A TRANSVERSE BREAK BETWEEN THE 2ND AND 3RD HOLE FROM MIDLINE. AS THE EMERGENCY RELEASE (ER) PIN COMPONENT WAS NOT RECEIVED FOR LOT 6741934, THE CONDITION OF A BROKEN PIN COULD NOT BE CONFIRMED. A (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THERE ARE VARIOUS UNKNOWN FACTORS THAT COULD CAUSE THE PLATE TO BE SUBJECT TO FORCES BEYOND THE YIELD STRENGTH OF THE MATERIAL. LOT 6760952: WHEN THE COMPONENTS ARE PLACED TOGETHER, IT WAS NOTED THAT THE PLATE HALVES EACH SHOW AN APPROXIMATELY 15 DEGREE CAUDAL BEND. THE PLATE SURFACES ALSO SHOW SIGNIFICANT WEAR AND INDENTS. THE FRACTURE SITES SHOW FLATTENING CONSISTENT WITH PRESSURE APPLIED AFTER THE BREAK. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR THE TOP LEVEL ASSEMBLY, THE STERNAL PLATE (MALE COMPONENT), THE STERNAL PLATE (FEMALE COMPONENT), AND THE ER PIN COMPONENT WAS PERFORMED. A DESIGN CHANGE UPDATED THE PLATE COMPONENTS IN DECEMBER, 2015. AS A RESULT OF THE LAND WIDTH CHANGE, THE LOCAL SECTION MODULUS WAS IMPACTED, BUT WITHOUT COMPROMISING THE OVERALL STRENGTH OF THE PLATE. SINCE THE POTENTIAL IMPACT OF THESE DESIGN ELEMENTS WAS CONSIDERED AND SHOWN TO HAVE NO IMPACT, IT CAN BE CONCLUDED THAT THE DESIGN CHANGE HAS BEEN VERIFIED TO MEET THE DESIGN INTENT OF THE DEVICE. THE CHANGE CONCERNED DEVICE ETCHINGS AND WAS DETERMINED TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE TECHNIQUE GUIDE STATES THAT SYNTHES RECOMMENDS A MINIMUM OF THREE PLATES IN THE STERNAL BODY FOR OPTIMAL STERNAL CLOSURE FOLLOWING A FULL STERNOTOMY AND THAT, SHOULD ONE PLATE BE USED IN COMBINATION WITH STAINLESS STEEL SURGICAL WIRES, SYNTHES RECOMMENDS USING A LEAST FOUR WIRES IN THE STERNAL BODY FOR CLOSURE OF A FULL STERNOTOMY. IF TWO PLATES ARE USED IN COMBINATION WITH STAINLESS STEEL WIRES, A MINIMUM OF TWO WIRES SHOULD BE USED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURE DATE: AUGUST 31, 2011. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO 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 5 NON-CONFORMANCE REPORTS / MATERIAL RECORD REPORTS WRITTEN AGAINST THIS LOT OF MATERIAL. HOWEVER, NONE OF THESE NCRS WOULD AFFECT THE FINISHED PRODUCT. THEREFORE, THE MATERIAL WAS DISPOSITIONED AS ¿USE AS IS¿ AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. CORRECTED DATA: MFR INFO. 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 PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE ONSET OF PECTORAL PAIN. THE PATIENT WAS ORIGINALLY TREATED FOR A PECTUS DEFECT ON AN UNKNOWN DATE WITH THE IMPLANTATION OF TWO (2) TITANIUM STERNAL LOCKING STRAIGHT PLATES AND AN UNKNOWN NUMBER OF LOCKING SCREWS. SOMETIME THEREAFTER, THE PATIENT BEGAN REPORTING PAIN IN THE PECTORAL AREA. AN X-RAY IMAGE REVEALED A BREAK IN ONE (1) OF THE PLATES. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 TO UNDERGO A HARDWARE REMOVAL. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE BROKEN PLATE HAD ACTUALLY BROKEN IN TWO (2) AREAS, LEAVING THE DEVICE IN THREE (3) SEPARATE PIECES. CONCERNING THE OTHER PLATE, IT WAS DISCOVERED THAT THE PIN WHICH HOLDS THE PLATE TOGETHER HAD ALSO BROKEN. AS A RESULT, THE PLATE WAS NO LONGER ARTICULATING. THE SURGEON REMOVED ALL OF THE ORIGINALLY IMPLANTED HARDWARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF SURGICAL DELAY OR ADDITIONAL PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202435 TI STERNAL LOCKING STRAIGHT PLATE-20 HOLES PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 6760952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention