BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW AXSOS 3 TI 4.0MM / L46MM

    MDR report key: 6246912 · Received January 12, 2017

    Report

    Report Number
    0008031020-2017-00026
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    October 30, 2016
    Report Date
    March 10, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K123964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: CHANGED TO YES. THE REPORTED EVENT THAT 7 SCREWS BACKED OUT FROM THE PLATE COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY INCORRECT SELECTION AND PLACEMENT OF THE SCREWS IN THE PLATE. THE X-RAYS PROVIDED SHOWED THAT 7 SCREWS WERE BACKED OUT OF THE PLATE IN THE PROXIMAL END. THESE SCREWS WERE RETURNED AND INSPECTED AND DESPITE OF THE USUAL MARKS OF USAGE (SCRATCHES IN THE TORX HEAD), NO OTHER DAMAGES WERE NOTICED. THE LOCKING THREADS ARE STILL COMPLETELY INTACT. A CLINICAL EVALUATION OF THE X-RAYS PROVIDED WAS REQUESTED AND, THE FOLLOWING WAS CONCLUDED: ¿THE GIVEN CASE PRESENTS A TYPICAL IMPLANT FAILURE CAUSED BY POOR SURGICAL TECHNIQUE (TOO SHORT LOCKING SCREWS IN THE HUMERAL HEAD AND INSUFFICIENT TIGHTENING OF THREE LOCKING SCREWS THAT WERE INSERTED IN THE PROXIMAL MAIN FRAGMENT).¿ BOTH CLINICAL EVALUATION AND INSPECTION POINT TO THE FACT THAT THE LOCKING SCREWS WERE NOT PROPERLY LOCKED IN THE PLATE. PROPER LOCKING CAN ONLY BE ACHIEVED BY THE CORRECT USE OF THE TORQUE LIMITER TO TIGHTEN THE SCREW AND PROVIDE THE APPROPRIATE TORQUE TO IT. MOREOVER THE CLINICAL EXPERT POINTED OUT THAT THE USAGE OF TOO SHORT SCREWS WHICH ULTIMATELY WAS WHAT LED TO THE FAILURE OF THE DEVICE. THE USE OF TOO SHORT SCREWS MEANS THAT THE THERE WAS NOT ENOUGH GRIP ON THE BONE SO THE SCREWS WERE NOT SECURELY ATTACHED. NOTE, AS STATED IN THE IFU (V15013): ¿4 WARNINGS AND PRECAUTIONS: IMPLANT SELECTION AND SIZING: THE CORRECT SELECTION OF THE FRACTURE FIXATION APPLIANCE IS EXTREMELY IMPORTANT. FAILURE TO USE THE APPROPRIATE APPLIANCE FOR THE FRACTURE CONDITION MAY ACCELERATE CLINICAL FAILURE. FAILURE TO USE THE PROPER COMPONENT TO MAINTAIN ADEQUATE BLOOD SUPPLY AND PROVIDE RIGID FIXATION MAY RESULT IN LOOSENING, BENDING, CRACKING OR FRACTURE OF THE DEVICE AND/OR BONE. THE CORRECT IMPLANT SIZE FOR A GIVEN PATIENT CAN BE DETERMINED BY EVALUATING THE PATIENT¿S HEIGHT, WEIGHT, FUNCTIONAL DEMANDS AND ANATOMY. EVERY IMPLANT MUST BE USED IN THE CORRECT ANATOMIC LOCATION, CONSISTENT WITH ACCEPTED STANDARDS OF INTERNAL FIXATION.¿ NOTE, AS STATED IN THE OPERATIVE TECHNIQUE (AXSOS-ST-14-EN REV 1 AXSOS 3 TITANIUM PROXIMAL HUMERUS OPTECH_2015-6882): ¿NOTE: CORRECT LENGTH OF THE LOCKING SCREWS IN THE HUMERAL HEAD ARE ESSENTIAL. PARTICULARLY IN OSTEOPENIC BONE, THERE IS ONLY LIMITED SUBSTANTIAL CANCELLOUS BONE STRUCTURE CLOSE TO THE SUBCHONDRAL COMPACTA PROVIDING RELIABLE STRENGTH FOR A BONE SCREW. TOO CLOSE OF A DISTANCE OF THE SCREW TIP TO THE SUBCHONDRAL COMPACTA BEARS AN INCREASED RISK OF CUT OUT IN THE CASE OF POSTOPERATIVE BONE SINTERING. FINAL TIGHTENING OF THE LOCKING SCREW IS ALWAYS PERFORMED BY HAND USING THE 2.5NM TORQUE LIMITER (702760) IN COMBINATION WITH A SCREWDRIVER BIT T15 (705015) AND THE T-HANDLE (702427). PERFORMING FINAL TIGHTENING BY HAND WILL HELP TO PREVENT OVER-TIGHTENING OF LOCKING SCREWS, AND ALSO ENSURES THAT THESE SCREWS ARE TIGHTENED TO A TORQUE OF 2.5NM. THE DEVICE WILL CLICK WHEN THE TORQUE REACHES 2.5NM. ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, AND DO NOT ANGULATE THE SCREWDRIVER.¿ A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CONDITION AFTER MULTIPLE PROXIMAL HUMERAL PLEXUS FRACTURE, WHICH WAS PROVIDED WITH THE AXOS HUMERUS PLATE AT THE END OF (B)(6) 2016. THROUGHOUT, THE PATIENT MOAN ABOUT PAIN IN THE AREA OF THE OPERATED ARM. IN AN X-RAY INSPECTION IT WAS SHOWN THAT A TOTAL OF 7 SCREWS WERE LOOSENED, ONE OF THESE SCREWS WAS COMPLETELY EXTRAOSSARY. CLINICALLY AND PARACLINICALLY, INFECTIONS COULD BE EXCLUDED. THE PLATE WAS REFIXED IN A REVISION SURGERY.

    Description of Event or Problem · 1

    CONDITION AFTER MULTIPLE PROXIMAL HUMERAL PLEXUS FRACTURE, WHICH WAS PROVIDED WITH THE AXOS HUMERUS PLATE AT THE END OF (B)(6) 2016. THROUGHOUT, THE PATIENT MOAN ABOUT PAIN IN THE AREA OF THE OPERATED ARM. IN AN X-RAY INSPECTION IT WAS SHOWN THAT A TOTAL OF 7 SCREWS WERE LOOSENED, ONE OF THESE SCREWS WAS COMPLETELY EXTRAOSSARY. CLINICALLY AND PARACLINICALLY, INFECTIONS COULD BE EXCLUDED. THE PLATE WAS REFIXED IN A REVISION SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29211 LOCKING SCREW AXSOS 3 TI 4.0MM / L46MM PLATE, FIXATION, BONE HRS STRYKER GMBH V24099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention