BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TI MATRIXRIB LCKNG SCREWSELF-TAPPING/14MM

    MDR report key: 2914059 · Received January 14, 2013

    Report

    Report Number
    8030965-2013-00126
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION ALSO COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES A TOTAL OF 10 SCREWS WERE RETURNED WITH THE BROKEN PLATE. SIX SCREWS WERE STUCK IN THE PLATE AND FOUR SCREWS WERE SEPARATED. A VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO BREAKAGE OR ANY OTHER DAMAGE VISIBLE AT THE SCREWS. A FUNCTION TEST WITH THE LOOSE SCREWS WAS PERFORMED AND IT WAS POSSIBLE TO LOCK THEM IN THE PLATE AS REQUIRED. AS THE OTHER SCREWS WERE STILL LOCKED IN THE PLATE IS AN INDICATION THAT THEY WERE ALSO FUNCTIONAL. BASED ON THESE FINDINGS IT WAS EVIDENT THAT THE SCREWS DID NOT CONTRIBUTE TO THE BREAKAGE OF THE PLATE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO CONDUCTED. FROM A DESIGN PERSPECTIVE, THERE ARE SEVERAL POTENTIAL CAUSES OF PLATE BREAKAGE INCLUDING SURGICAL TECHNIQUE, BONE QUALITY, PATIENT COMPLIANCE, DEVICE MATERIAL PROPERTIES AND DEVICE DESIGN. THE CASE WAS DISCUSSED WITH THE SALES CONSULTANT AND HE DID NOT NOTE ANY PROBLEMS WITH THE SURGICAL TECHNIQUE NOR WITH PATIENT NON-COMPLIANCE. THE SALES CONSULTANT DID CONFIRM THAT THE BONE WAS HEALED WHEN THE DEVICE WAS REMOVED. IT SHOULD BE NOTED THAT THE DEVICE HAD BEEN IMPLANTED FOR OVER 2 YEARS BASED ON THE PROVIDED IMPLANTATION DATE AND SINCE THE BONE WAS HEALED, THIS SUGGESTS THE DEVICE BROKE AFTER BONE HEALING. WITH THIS INFORMATION, IT IS DIFFICULT TO DETERMINE AN EXACT CAUSE, BUT THE MATERIAL PROPERTIES AND THE DESIGNED STRENGTH OF THE PLATES CAN ALSO BE CONSIDERED. THE MATERIAL SELECTED FOR THIS PLATE IS TAN ((B)(4)) WHICH IS A STANDARD MATERIAL FOR THIS TYPE OF DEVICE AND IS USED FOR ITS BIOCOMPATIBILITY AND STRENGTH. IN TERMS OF DESIGN, THE STRENGTH OF THESE PLATES WAS VERIFIED AND VALIDATED VIA MECHANICAL AND CADAVERIC BEND TESTING TO MEET THE DESIGN CRITERION OF BEING COMPARABLE TO THE NATIVE STRENGTH OF RIBS OF OSTEOPOROTIC BONE QUALITY. THIS DESIGN CRITERION WAS CHOSEN TO MITIGATE THE RISK FOR SCREW PULL-OUT AND PERIPROSTHETIC FRACTURE ESPECIALLY IN PRESENCE OF OSTEOPOROTIC BONE. THE DESIGN OF THE PLATE WAS VERIFIED AND VALIDATED TO MEET THE DESIGN CRITERIA. CORRECTED DATA: (B)(4). (B)(6). THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    MDR DETERMINATION REVISED; EXPLANT SURGERY PERFORMED.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT THAT: ON (B)(6) 2012 THE SURGEON INFORMED HIM OF A PATIENT WITH A BROKEN MATRIX RIB PLATE (6TH/7TH RIB). THE SURGEON PLANS TO REVISE THE PATIENT AND REMOVE THE PLATE ON AN UNKNOWN DATE IN JANUARY 2013. PRODUCT LOT NUMBER AND ADDITIONAL INFORMATION WILL BE PROVIDED UPON REVISION. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    INITIALLY REPORTED: A REPORT WAS RECEIVED ON (B)(4) 2012 OF A PATIENT WITH A BROKEN MATRIX RIB PLATE (6TH/7TH RIB). UPDATE: THE PLATES AND SCREWS WERE REMOVED FROM THE PATIENT ON (B)(6) 2013. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21084 2.9MM TI MATRIXRIB LCKNG SCREWSELF-TAPPING/14MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention