BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 46MM

    MDR report key: 4143499 · Received October 6, 2014

    Report

    Report Number
    3009450884-2014-10074
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). EVENT DATE: UNKNOWN. ORIGINAL IMPLANT WAS ON AN UNKNOWN DATE IN (B)(6) 2013. MANUFACTURING EVALUATION: THE SCREW SHOWED DEFORMATION AND DIMPLES IN COUNTERCLOCKWISE ORIENTATION. SHEAR DIMPLES WERE OBSERVED AT THE CRACK PROPAGATION ZONE AND OVER A SIZEABLE AREA. THE PRESENCE OF THESE SHEAR DIMPLES IS A CLEAR INDICATION OF EXCESSIVE TORSIONAL OVERLOAD. BASED ON THE ORIENTATION OF THE SHEAR DIMPLES IT CAN BE STATED, THAT THE SCREW BROKE DURING LOOSENING / REMOVAL. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE SCREW FAILURE WAS CAUSED BY COUNTERCLOCKWISE TORSIONAL OVERLOAD DURING LOOSENING. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS THE SECOND REVISION OF THE SURGERY. THIS PATIENT ORIGINALLY HAD A PERIPROSTHETIC FRACTURE ON AN UNKNOWN DATE IN (B)(6) 2013. THE FIRST REVISION SURGERY WAS NON SYNTHES PLATE, AFTER THE IMPLANT FAILURE THE PATIENT WAS TREATED FOR A SECOND REVISION. A REFRESH OF THE TWO BONE ENDS AND RESECTION OF BOTH SIDES ON THE BONE WAS DONE AND A LITTLE VALGUS POSITION WAS LEFT. THE SECOND REVISION WAS COMPLETED WITH A NON SYNTHES PLATES ON THE VENTRAL SIDE AND A DYNAMIC COMPRESSION PLATE WITH A LESS INVASIVE STABILIZATION SYSTEM FOR DISTAL FEMUR. A SYNTHETIC BONE GRAFT WAS ALSO USED. THE PLATE BROKE ON AN UNKNOWN DATE IN (B)(6) 2014. IT WAS ALSO REPORTED THAT PER AN INTERNAL REVIEW BY THE MEDICAL DIRECTOR; A PERIPROSTHETIC FRACTURE WAS DETERMINE BY THE X-RAY IMAGES. PER ADDITIONAL INFORMATION RECEIVED; THERE WAS PLATE BROKEN AND THERE WAS IS A SCREW THAT IS STUCK IN THE PLATE. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623213 4.5MM TI CORTEX SCREW SELF-TAPPING 46MM SCREW,FIXATION,BONE HWC SYNTHES GRENCHEN 8409155

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention