BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 4203661 · Received October 27, 2014

    Report

    Report Number
    0009610622-2014-00575
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 28, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICES COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT AVAILABLE. THE EVENT WAS NOT CONFIRMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED DUE TO LACK OF INFORMATION. THE CUSTOMER CONFIRMED THAT THE REQUESTED FURTHER INFORMATION WILL NOT BE PROVIDED. WITH RESPECT TO THE INVESTIGATION RESULTS AND INFORMATION AVAILABLE THE REAL CAUSE OF THE EVENT (SCREW BACK OUT) COULD NOT BE DETERMINED BUT MIGHT BE CONTRIBUTED BY THE PATIENT¿S CONDITION (POOR BONE QUALITY CAN BE EXPECTED ASSOCIATED WITH PHN TREATMENT). POTENTIAL REASONS FOR SCREW BACK OUT ARE VARIOUS: ¿ THE NYLON BUSHING WILL FURTHER IMPROVE THE HOLDING STRENGTH OF THE SCREWS AND HELPS AVOID SCREW BACK OUT AND ALSO STOP SCREW TOGGLE. IF THE PROXIMAL LOCKING HOLES HAVE NO NYLON BUSHING THE SCREWS HAS NO RESISTANCE AGAIN BACK OUT IF THE NYLON BUSHING IS DAMAGED A FULL FUNCTION IS NOT GIVEN ¿ IF THE SCREWS ARE NOT SEATED ON THE BONE SURFACE THE STABILITY AND FIXATION OF THE SCREW IS NOT FULLY GIVEN. REFER TO THE OP-TECHNIQUE EXCERPTS ABOUT THE SCREWDRIVER GROOVE AS IMPLANTATION HELP IF THE SURGEON USED TOO LONG SCREWS THE SCREW HEAD CAN NOT CONNECTED WITH THE BONE SURFACE. IF THE TISSUE SLEEVE IS TOO FAR AWAY FROM THE BONE SURFACE, THE SURGEON HAS A GAP BETWEEN THE BONE SURFACE AND THE SCREW HEAD WHEN THE SCREWDRIVER GROOVE REACHES THE TISSUE PROTECTION SLEEVE END. IF THE SURGEON DO NOT USE THE VISUALISATION TOOLS DURING THE SURGERY A WRONG PLACED SCREW CAN NOT DETECTED. ¿ IF THE PROXIMAL NAIL HOLES HAVE NO THREADING THERE IS NO FIXATION OF THE SCREWS. ¿ IF THE WRONG DRILL WAS USED DURING SURGERY THE THREAD AND THE NYLON BUSHING WILL BE DAMAGED. THE OP-TECHNIQUE REFERS THAT A 3.5MM DRILL SHOULD BE USED FOR THE HOLE DRILLING. IF THE USER TAKES A 5MM DRILL THE CUTTING EDGES DAMAGE THE THREAD OF THE HOLE AND THE NYLON BUSHING. THE RESULT IS A LOWER FIXATION OF THE LOCKING SCREWS AND COULD BE END IN SCREW MOVING. ¿ DRILLING WITHOUT DRILL GUIDING SLEEVE. ¿ USING BLUNT OR DAMAGED DRILL. ¿ HIGH FORCES APPLIED TO THE TARGET DEVICE DURING DRILLING ¿ EVENTUALLY LEADING TO UNINTENDED DISTORTION IN THE SYSTEM OF DRILL, SLEEVE, TARGET DEVICE AND NAIL. A REAL ROOT CAUSE WITH THESE EVIDENCES COULD NOT BE DETERMINED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    AFTER T2PH NAIL SURGERY, SCREW BACKOUT WAS CONFIRMED. REVISION SURGERY WAS PERFORMED. THIS CASE WAS PRESENTED AT THE MEETING OF (B)(4) SOCIETY FOR FRACTURE REPAIR ON (B)(6) 2014. IT IS THE 3RD CASE OF THREE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682430 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention