BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX

    MDR report key: 9756304 · Received February 26, 2020

    Report

    Report Number
    8030965-2020-01413
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819331075
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: PART: 03.008.009 LOT: 3L02844 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: APRIL 3, 2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RETURNED AIM-ARM F/EXPERT HAN WAS FORWARDED TO THE MANUFACTURING SIDE FOR EVALUATION. THE STATEMENT BELOW IS A SUMMARY OF THEIR INVESTIGATION. SHIPPED BACK DEVICE ¿AIM-ARM F/EXPERT HAN F/03.008.007¿ ARTICLE NUMBER 03.008.009 WITH LOT NUMBER 3L02844 IS IN USED CONDITIONS. HOWEVER, NO SIGNS OF DAMAGE ARE PRESENT ON THE DEVICE AND IT LOOKS ABLE TO PROPERLY FUNCTION. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED ON ¿AIM-ARM F/EXPERT HAN F/03.008.007¿ ARTICLE NUMBER 03.008.009 WITH LOT NUMBER 3L02844 ACCORDING TO INSPECTION SHEET IN ORDER TO INVESTIGATE ON THE COMPLAINT DESCRIPTION: - FUNCTIONAL TEST USING FUNCTIONAL GAUGE 50171481 WITH ID NUMBER 7374-H, FUNCTIONAL GAUGE 50163412 WITH ID NUMBER 7113-H AND FUNCTIONAL GAUGE 50161303 WITH ID NUMBER 9023-H. THE DEVICE PASSED THE TESTS PERFORMED; - DIMENSIONS AND POSITIONS WERE MEASURED ACCORDING TO PRUFPLAN USING 3D-KMG TESTING EQUIPMENT WITH ID NUMBER 6936-H. ALL THE FEATURES RESULTED INSIDE THE SPECIFICATIONS; THEREFORE, THE TEST WAS PASSED. - FURTHER DIMENSIONS WERE MEASURED USING 3D-KMG TESTING EQUIPMENT WITH ID NUMBER 6936-H AND PART OF THE PRUFPLAN SINCE THE PROGRAM WOULD INVOLVE ONLY COMPONENT 60028995 BEFORE THE ASSEMBLY WITH COMPONENT 60028996. FOR THIS REASON, THE FEATURES WE WERE ABLE TO MEASURE WERE THE ONES NOT COVERED BY THE FOLLOWING ASSEMBLY. THE DEVICE PASSED THE TEST. SINCE THE DEVICE ¿AIM-ARM F/EXPERT HAN F/03.008.007¿ ARTICLE NUMBER 03.008.009 WITH LOT NUMBER 3L02844 PASSED ALL THE TESTS PERFORMED IT WAS NOT POSSIBLE TO REPLICATE THE COMPLAINT. THE FOLLOWING DOCUMENTS WERE REVIEWED: -DEVICE HISTORY RECORD (DHR) -INSPECTION SHEET S -DRAWING 0 -DRAWING IN ORDER TO PERFORM THE INVESTIGATION, ALL THE DOCUMENTS MENTIONED ABOVE, VALID WHEN THE DEVICE WAS MANUFACTURED, HAVE BEEN ANALYZED. THE MANUFACTURING PROCESS WAS EXECUTED ACCORDING TO THE ANALYZED DOCUMENTS AND NO ANOMALIES WERE IDENTIFIED. ACCORDING TO EVIDENCES IS NOT POSSIBLE TO ADDRESS THE FINAL ROOT CAUSE TO A MANUFACTURING ISSUE. THE MANUFACTURING PROCESS WAS PERFORMED ACCORDING TO THE REVIEWED DOCUMENTS AND ALL FUNCTIONAL TEST WERE RECORDED. MOST LIKELY A MISHANDLING OF THE DEVICE COULD HAVE LED TO THE OPENING OF THIS COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 DURING A REMOVAL OF A BROKEN NAIL AND REVISION FUSION LEFT TIBIO-TALO-CALCANEAL FUSION WITH BONE GRAFT, THAT A PATIENT ON FOLLOW UP OF PREVIOUS PROCEDURE FOUND TO HAVE BROKEN PREVIOUSLY IMPLANTED TORNIER / WRIGHT MEDICAL 611 NAIL (12MM X 180MM). BREAKAGE ABOVE THE PROXIMAL CALCANEAL SCREW. REVISION BOOKED, WITH CONSULTANT REQUESTING DPS NAIL REMOVAL, RIA AND HAN, AS WELL AS WRIGHT 611 REMOVAL SET. BROKEN NAIL EXTRACTED, WITH DIFFICULTY REMOVING PROXIMAL END OF THE BROKEN NAIL. WINDOW IN PATIENT TIBIA CREATED IN ORDER TO ASSIST WITH REMOVAL. SURGEON SELECTED HAN 13MM X 240MM LEFT NAIL, WHICH WAS CHECKED, PRIOR TO BEING ASSEMBLED ONTO AIMING DEVICE. ALIGNMENT TEST COMPLETE PRIOR TO NAIL INSERTION IN LINE WITH THE SURGICAL TECHNIQUE WITH NO FAULTS NOTED. ON INSERTION OF THE NAIL, THE SURGEON AGAIN VERIFIED NAIL IN CORRECT ALIGNMENT VIA INTRA OP X-RAY AND CONFIRMED NAIL TO BE LOCKED INTO POSITION. SURGEON ELECTED TO USE TWO DISTAL LOCKING SCREWS THROUGH NAIL AS INDICATED, HOWEVER ON PLACING PROTECTION SLEEVE IN MOST DISTAL LOCKING SCREW POSITION, AND DRILLING, FOUND THE DRILL TO BE HITTING THE NAIL, RATHER THAN TARGETING THE SCREW HOLE. DECISION MADE BY THE SURGEON TO RECHECK TIGHTNESS OF AIMING DEVICE, AND TARGET THE SECOND MOST DISTAL HOLE INSTEAD, WITH NO ISSUE FOUND. UPON ATTEMPTING TO LOCK ALL REMAINING SCREW OPTIONS, FOUND AGAIN THE DRILL TO AIMING AT THE NAIL, RATHER THAN SCREW HOLES. DECISION MADE TO USE THE FREEHAND TECHNIQUE TO PLACE REMAINING LOCKING SCREWS. 45 MINUTES DELAY IN THE SURGERY. THE PATIENT IS WELL. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS 3 OF 6 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220874 AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 3L02844 07611819331075

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR CONNECSCR CANN W/INTERNAL M6X1 THREAD| EXPERT HAN Ø13 LE CANN L240 TAN LIGHT GR| INSERT-HANDLE F/EXPERT HAN| THREADED ALIGNMPIN F/04.008.003| UNK - DRILL BITS: TRAUMA