BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 4704484 · Received April 17, 2015

    Report

    Report Number
    9612488-2015-10242
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    March 28, 2015
    Report Date
    March 29, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED: THE PRODUCT WAS RETURNED IN A PLASTIC BAG. THE LASER ETCHING WAS READABLE. THERE ARE TRACES OF UTILIZATION VISIBLE. THE THREAD OF THE CONNECTING SCREW IS PARTIAL RAGGED. A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES WHICH COULD LEAD TO THE COMPLAINT FAILURE WERE DETECTED. THE DIMENSIONS, WHICH WERE POSSIBLE TO BE MEASURED AND HAVE A POTENTIAL RELEVANCE FOR THE FUNCTION OF THE PRODUCT WERE EVALUATED, WITH THE RESULT, THAT THEY FULFILL THE SPECIFICATIONS. AS THE REGION OF THE THREAD IS PARTIAL RAGGED ADDITIONAL THE HARDNESS OF THE ITEM WAS INVESTIGATED, WITH THE RESULT, THAT IT MEETS THE SPECIFICATIONS. THERE ARE NO INDICATIONS AVAILABLE, WHICH LEAD TO THE CONCLUSION THAT THE COMPLAINT IS CAUSED BY THE MANUFACTURING PROCESS. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT AS NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    ADDITIONAL NARRATIVE: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SURGICAL DELAY WAS CAPTURED IN REPORT 1 FOR (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 AFTER CHOOSING THE NAIL WITH A DIAMETER OF 9MM AND LENGTH OF 400, THE SURGEON INSERTED THE START GUIDE WITH THE DRILL AND THEN PASSED THE DRILL BIT TO INTRODUCE THE NAIL. WHEN THE SURGEON INSERTED A NAIL BELOW THE MINOR TROCHANTER, THE SURGEON SAW THAT THE CHANNEL WAS NARROW AND STARTED TO IMPACT STRONGLY WITH THE HAMMER. THERE WAS FATIGUE WITH THE CONNECTION SCREW AND THE SURGEON REALIZED THAT THE HOLES AT THE DISTAL END OF THE NAIL HAD BROKEN. THE SURGEON DECIDED TO REAM THE INTRAMEDULLARY CANAL AND USE A NAIL WITH A DIAMETER OF 9MM AND LENGTH OF 420. THE SURGEON USED A 4.0MM DRILL BIT TO PERFORM THE PLACEMENT OF THE DISTAL PINS IN THE PROXIMAL PART. WHEN THE SURGEON WAS PUTTING THE BOLTS IN THERE WAS SOME DIFFICULTY WHEN THE SCREW STRIPPED/LOST ITS THREAD.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE IMPLANTATION OF A 9MM DIAMETER, 400MM LENGTH NAIL IT WAS OBSERVED THAT THE PATIENT¿S INTRAMEDULLARY CANAL WAS VERY NARROW BELOW THE LESSER TROCHANTER. THE SURGEON, HOWEVER, CHOOSE TO CONTINUE IMPACTION WITH THE SLIDE HAMMER USING MORE FORCE AND FATIGUE OCCURRED AT THE CONNECTING SCREW. THIS RESULTED IN A FAILURE OF THE CONNECTING SCREW TO HOLD PROPERLY. IT WAS ALSO DISCOVERED THAT THE NAIL HAD BROKEN AT THE DISTAL NAIL HOLES. REPLACEMENT DEVICES WERE NOT AVAILABLE SO EXTRACTION DEVICES WERE TO REMOVE THE BROKEN NAIL. DURING THE NAIL EXTRACTION, THE EXTRACTION SCREW BECAME STUCK TO THE SLIDE HAMMER AND THE NAIL BECAME STUCK TO THE SLOTTED HAMMER. THE SURGEON THEN RE-REAMED THE INTRAMEDULLARY CANAL. A 9MM, 420MM LENGTH NAIL WAS THEN IMPLANTED. THERE IS NO ALLEGATION OF COMPLAINT AGAINST THIS NAIL. THE SURGEON THEN PLACED THE DISTAL PINS AND PLACED THE DYNAMIC HOLE PROXIMALLY USING A 4.00MM DRILL BIT. DURING THE INSERTION OF TWO LOCKING SCREWS, THERE WAS DIFFICULTY OBTAINING PROPER TIGHTNESS AND SECURITY¿THE SCREWS APPEARED TO HAVE STRIPPED/LOST THEIR THREAD AND WOULD NOT HOLD; HOWEVER, THERE WAS NO REPORT OF SCREW FRAGMENTS BEING GENERATED. A ZERO EXTENSION LOCKING SCREW WAS IMPLANTED. THERE IS NO ALLEGATION OF COMPLAINT AGAINST THE ZERO EXTENSION LOCKING SCREW. THERE WAS A 60 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENTS. THE SURGERY WAS COMPLETED AND THE PATIENT IS REPORTEDLY FINE. THIS REPORT IS 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257318 CONNECSCR F/CFN/AFN F/SYNREAM GUIDE FZX SYNTHES BETTLACH 2561831

    Patients

    Seq Age Sex Outcome Treatment
    1