BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERAL NAIL, CANNULATED, RIGHT T2 PROX. HUM. Ø8 X 150 MM

    MDR report key: 3191980 · Received June 27, 2013

    Report

    Report Number
    0009610622-2013-00358
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION OF THE DEVICES COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT AVAILABLE. ACCORDING TO THE X- RAY RECEIVED- A BACK-OUT OF 2ND PROXIMAL SCREW CAN ONLY BE ASSUMED. A REVIEW OF THE DHR FOR THE PROXIMAL HUMERAL NAIL AND BOTH PROXIMAL SCREWS REVEALED NO DISCREPANCIES. WITH RESPECT TO THE INVESTIGATION RESULTS AND INFORMATION AVAILABLE THE REAL CAUSE OF THE EVENT (SCREW BACK OUT) COULD NOT BE DETERMINED. 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 CANNOT 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 DOES NOT USE THE VISUALISATION TOOLS DURING THE SURGERY A WRONG PLACED SCREW CANNOT BE 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. RESULT: A MANUFACTURER FAULT COULD BE EXCLUDED ACCORDING TO THE MANUFACTURING RECORDS. ALL PROXIMAL THREAD HOLES OF THE NAIL WERE TESTED FOR 100% FUNCTION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, T2PH SURGERY WAS PERFORMED. AFTER THAT THE PATIENT COMPLAINED OF DISCOMFORT AND PAIN, IT WAS FOUND THAT THE SECOND SCREW FROM THE PROXIMAL WAS BACKED OUT. FOLLOW-UP IS BEING CARRIED OUT NOW AND EXTRACTION IS PLANED ON (B)(6) 2013.

    Description of Event or Problem · 1

    ON 2013 (B)(6) T2PH SURGERY WAS PERFORMED. AFTER THAT THE PATIENT COMPLAINED OF DISCOMFORT AND PAIN, IT WAS FOUND THAT THE SECOND SCREW FROM THE PROXIMAL WAS BACKED OUT. FOLLOW-UP IS BEING CARRIED OUT NOW AND EXTRACTION IS PLANED ON 2013 (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294814 PROXIMAL HUMERAL NAIL, CANNULATED, RIGHT T2 PROX. HUM. Ø8 X 150 MM IMPLANT HSB STRYKER TRAUMA KIEL K263519

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention