BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTEX SCREW S.T. Ø3.5X30MM

    MDR report key: 3930810 · Received July 12, 2014

    Report

    Report Number
    0008031020-2014-00308
    Event Type
    Injury
    Date Received
    July 12, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K050512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE FOUR BROKEN SCREWS TO BE THE PRIMARY PRODUCTS. ALL OTHER IMPLANTS WERE CLASSIFIED AS CONCOMITANT ITEMS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE SCREWS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE BREAKAGE SURFACES OF THE FOUR BROKEN SCREWS SHOW A SMOOTH STRUCTURE; LINES OF REST ARE VISIBLE, INDICATING THAT THE SCREWS BROKE STEP BY STEP IN A FATIGUE FRACTURE. THE THREAD WINDINGS OF ALL FOUR SCREWS ARE HEAVILY DEFORMED AND DAMAGED NEAR THE BREAKAGE SURFACES; MOST LIKELY CAUSED BY FORCEPS DURING EXPLANTATION. THE TORX- AND HEXAGON PROFILES OF THE SCREWS SHOW SIGNS OF USAGE BUT NO STRIPPING MARKS OR OTHER SIGNIFICANT DEFORMATIONS; INDICATING THAT NO UNUSUAL TORQUE FORCE WERE APPLIED TO THE SCREWS DURING IMPLANTATION. THE PROVIDED X-RAYS SHOW ONLY TWO BROKEN SCREWS AND A PART OF THE PLATE, BUT NOT WHICH PLATE WAS USED, HOW MANY SCREWS WERE USED OR WHICH KIND OF FRACTURE WAS TREATED. FURTHERMORE THE PATIENT¿S HEIGHT, WEIGHT AND POSTOPERATIVELY MOBILIZATION DETAILS WERE NOT PROVIDED. THE CUSTOMER REPORTED THAT THE BONE FRACTURE WAS FOUND HEALED DURING THE REVISION SURGERY. ALTHOUGH FOUR SCREWS GOT BROKEN THE PLATE AND THE OTHER FOUR SCREWS TREAT THE FRACTURE SUCCESSFULLY UNTIL IT GOT HEALED. THE FOUR SCREWS BROKE DUE TO A FATIGUE FRACTURE, INDICATING THAT POSTOPERATIVELY LOADS WERE APPLIED TO THE IMPLANTS. IT IS MOST LIKELY THAT SEVERAL LOADS WERE APPLIED TO THE IMPLANTS SHORTLY AFTER THE IMPLANTATION (FRACTURE WAS NOT HEALED AT TIME OF SCREW BREAKAGES); OVERLOADING DUE TO OBESITY AND POOR BONE FORMATION / POOR BONE STRUCTURE CANNOT BE EXCLUDED. THE IFU INCLUDES THAT POSTOPERATIVE LOADS, OBESITY, POOR BONE FORMATION OR POOR BONE STRUCTURES ARE ADVERSE EFFECTS THAT CAN LEAD TO IMPLANT FAILURES LIKE BREAKAGES. BECAUSE NO INDICATION FOR ANY MANUFACTURER RELATED ISSUES WERE FOUND DURING THE INVESTIGATION THE CASE IS ATTRIBUTED TO A POSTOPERATIVELY OVERLOAD BY THE PATIENT. NO NONCONFORMITY IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAD ANKLE SURGERY IN (B)(6) OF 2013. IT WAS CONFIRMED ON X-RAY THAT THERE WERE 4 BROKEN SCREWS (2 CORTICAL, 2 AXSOS STAINLESS STEEL 4.0 LOCKING SCREWS). REVISION OCCURRED ON (B)(6) 2014. AT THAT POINT, SURGEON NOTICED THAT THE ANKLE HAD HEALED. ALL HARDWARE WAS REMOVED. NO PRESENCE OF FRACTURE. HE INJECTED HYRDOSET INTO ONE OF THE BONY VOIDS AND CLOSED OUT SURGERY.

    Description of Event or Problem · 1

    PATIENT HAD ANKLE SURGERY IN (B)(6) 2013. IT WAS CONFIRMED ON X-RAY THAT THERE WERE 4 BROKEN SCREWS (2 CORTICAL, 2 AXSOS STAINLESS STEEL 4.0 LOCKING SCREWS). REVISION OCCURRED ON (B)(6) 2014. AT THAT POINT, SURGEON NOTICED THAT THE ANKLE HAD HEALED. ALL HARDWARE WAS REMOVED. NO PRESENCE OF FRACTURE. HE INJECTED HYRDOSET INTO ONE OF THE BONY VOIDS AND CLOSED OUT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408579 CORTEX SCREW S.T. Ø3.5X30MM PLATE, FIXATION, BONE HRS STRYKER GMBH Z17046

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention