BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 8MM

    MDR report key: 3942315 · Received July 17, 2014

    Report

    Report Number
    2520274-2014-12658
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEDWATCH REPORT FOR THIS EVENT WAS ORIGINALLY FILED AS A PRODUCT PROBLEM AND ADVERSE EVENT. THE INVESTIGATION OF THE RETURNED DEVICES WAS ABLE TO DETERMINE THE SPECIFIC PART(S ) INVOLVED IN THIS EVENT THAT HAD A PRODUCT PROBLEM. IT WAS DETERMINED NO PRODUCT FAULT OCCURRED WITH THIS PART THEREFORE THIS REPORT IS A CORRECTION TO REFLECT ONLY AN ADVERSE EVENT. 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

    (B)(6). A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RETURNED THIRTEEN UNKNOWN SCREWS WERE IDENTIFIED BY THE CHU ENGINEER BASED ON THEIR DIMENSIONS, FEATURES, AND USE. ADDITIONALLY, BASED ON THE WEAR OF THE IMPLANTS AND THE X-RAY, THE LOCATION OF THE IMPLANTS WAS DETERMINED. THE FOLLOWING IS THE RETURNED CONDITION AND HOLE LOCATION FROM THE PROXIMAL END BASED ON THESE IDENTIFICATIONS. ONE 2.7MM VARIABLE ANGLE LOCKING SCREW, PART NUMBER 02.211.018, WAS RECEIVED WITH SMALL NICKS IN THE THREADS AND LIKELY USED IN THE 1ST HOLE. ONE 2.7MM VARIABLE ANGLE LOCKING SCREW, PART NUMBER 02.211.022, WAS RECEIVED WITH A DIAGONAL GOUGE IN THE THREADS THAT REDUCED THE DIAMETER BY APPROXIMATELY A THIRD. THE GOUGE WAS ABOUT HALFWAY DOWN THE THREADS AND THERE WERE ADDITIONAL SMALL NICKS ON THE THREADS. THIS SCREW WAS LIKELY USED IN THE 3RD HOLE. THREE 2.7MM VARIABLE ANGLE LOCKING SCREWS, PART NUMBER 02.211.016, WERE RECEIVED WITH SMALL NICKS IN THE THREADS AND LIKELY USED IN THE 2ND, 4TH, AND 6TH HOLES. TWO 2.7MM VARIABLE ANGLE LOCKING SCREWS, PART NUMBER 02.211.026, WERE RECEIVED WITH WORN THREADS AND ONE HAD SMALL NICKS ON THE THREADS. THEY WERE LIKELY USED IN THE 5TH AND 10TH HOLES. TWO 2.7MM VARIABLE ANGLE LOCKING SCREWS, PART NUMBER 02.211.008, WERE RECEIVED WITH WORN THREADS AND LIKELY USED IN THE 7TH AND 8TH HOLES. ONE 3.5MM LOCKING SCREW, PART NUMBER 212.106, WAS RECEIVED WITH WORN THREADS AND LIKELY USED IN THE 13TH HOLE. ONE 3.5MM LOCKING SCREW, PART NUMBER 212.105, WAS RECEIVED WITH WORN THREADS AND LIKELY USED IN THE 14TH HOLE. TWO 3.5MM CORTEX SCREWS, PART NUMBER 204.820, WERE RECEIVED WITH WORN THREADS AND LIKELY USED IN THE 12TH AND 15TH HOLES. THE COMPLAINT CONDITION CANNOT BE REPLICATED BUT THE X-RAY CONFIRMS THE COMPLAINT CONDITION. THE OVERALL WEAR ON THE THREADS IS CONSISTENT WITH THE EXPECTED WEAR FROM USE. BASED ON THE IDENTIFIED ALIGNMENT, THE SCREW WITH THE GOUGE WAS IMPLANTED IN THE 3RD HOLE FROM THE PROXIMAL END SO THE MOST LIKELY CAUSE OF DAMAGE WAS FROM DRILLING FOR THE 5TH HOLE FROM THE PROXIMAL END. THE OTHER NICKS AND SCRATCHES ARE LARGELY CONCENTRATED ON THE SCREWS USED IN THE PROXIMAL END. THIS SHOWS EVIDENCE THAT THE DRILL BIT ANGLE WAS NOT CHECKED UNDER FLUOROSCOPY AS RECOMMENDED IN THE TECHNIQUE GUIDE OR THAT THE DRILL GUIDE FOR VARIABLE ANGLE DRILLING WAS NOT USED. THESE ARE BOTH STEPS FOR ENSURING THE SCREWS WILL NOT IMPACT EACH OTHER. THE TWO SCREWS THAT BACKED OUT OF THE 1ST AND 2ND PROXIMAL HOLES ARE LIKELY THE RESULT OF NOT BEING FULLY LOCKED INTO THE LOCKING HOLES. THIS COULD BE CAUSED BY NOT FULLY INSERTING THE SCREWS OR INSERTING AT AN ANGLE OUTSIDE THE DESIGNED 30 DEGREE CONE. HOWEVER, PATIENT ACTIVITY WOULD ALSO HAVE THE ABILITY TO IMPACT THE COMPLAINT CONDITION AND IT IS NOT SPECIFIED HOW THE SCREWS WERE INSERTED. THUS, THE ROOT CAUSE OF THE BACKED OUT SCREWS AND NON-UNION CANNOT BE DEFINITIVELY DETERMINED. IN CONCLUSION, THE COMPLAINT CONDITION HAS BEEN CONFIRMED AND THE ROOT CAUSE OF THE COMPLAINT CONDITION IS UNDETERMINED. THE DESIGNS WERE FOUND TO BE SUITABLE FOR THEIR INTENDED USE. DEVICE WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION SURGERY FOR A PATIENT WHO HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT OLECRANON ON (B)(6) 2013. X-RAYS WERE TAKEN POST-OPERATIVELY FROM INITIAL SURGERY ON (B)(6) 2013. THE X-RAYS TAKEN ON AN UNKNOWN DATE PRIOR TO REVISION SHOWED A NON-UNION AND SOME OF THE VARIABLE ANGLE LOCKING SCREWS BACKING OUT OF THE PLATE. DURING THE REVISION SURGERY ON (B)(6) 2014, THE SURGEON NOTICED ONE OF THE SCREWS THAT HE REMOVED HAD A GOUGE WITH A FRAGMENT MISSING. THE SURGEON REMOVED ALL FRAGMENTS. THE PLATE AND AN UNKNOWN NUMBER OF SCREWS WERE REMOVED. THE SURGEON IMPLANTED A DIFFERENT 3.5 LOCKING COMPRESSION PLATE WITH AN UNKNOWN NUMBER OF SCREWS. IT WAS REPORTED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THIS IS REPORT 16 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419679 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 8MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention