BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END-CAP F/A2FN CANN EXTENS. 10 TAN GREY

    MDR report key: 6589403 · Received May 24, 2017

    Report

    Report Number
    1000562954-2017-10076
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    April 26, 2017
    Report Date
    April 26, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S IDENTIFIER, DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. UDI: (B)(4). EXPLANT DATE: IMPLANTED; AS SUCH EXPLANT DATE IS NOT APPLICABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART: 04.009.002S, LOT: 9940091: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 19.MAY.2016, EXPIRY DATE: 01.MAY.2026: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS DISPOSED AS UNCONFIRMED AS ONLY THE 5MM END CAP ITEM WAS RETURNED FOR INVESTIGATION AND IT WAS FOUND CONFORMING. THE COUPLING WITH THE NAIL COULD NOT BE VERIFIED DUE TO THE FACT THAT THE NAIL WAS NOT RETURNED. THE RETURNED END CAP WAS RECEIVED IN USED CONDITION. TRACES OF USE ARE PRESENT ON THE PART SURFACE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. THE RETURNED PART WAS RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION. ALL THE FEATURES RELATED TO THE INSERTION OF THE END CAP INTO THE FEMORAL NAIL WERE VERIFIED AND RESULTED CONFORMING; NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEM, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE RETURNED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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 THE EXPERT ANTEGRADE 2 FEMORAL NAIL (A2FN) IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2017 TO TREAT THE DISTAL THIRD FRACTURE OF THE FEMORAL SHAFT. AFTER THE DISTAL FIXATION OF THE A2FN WAS DONE, PROXIMAL COMPRESSION WAS PERFORMED BY A BACK STROKE TECHNIQUE. WHEN THE SURGEON TRIED TO INSERT THE END CAP (10 MM DIAMETER) TO THE FEMORAL NAIL AFTER THE PROXIMAL LOCKING, THE SURGEON WAS UNABLE TO DO SO. SURGEON SUSPECTED FOR A POSSIBILITY IN CONNECTIVE TISSUE INVOLVEMENT; HOWEVER THERE WAS NO SUCH A PROBLEM. SURGEON THEN CHANGED, AND TRIED TO INSERT ANOTHER SIZE OF END CAP (5 MM DIAMETER), BUT HE WAS UNABLE TO DO SO EITHER. AT THE END, THE SURGEON FORCED THE END CAP (10 MM DIAMETER) INTO THE EXPERT A2FN. THE SURGERY WAS EXTENDED FOR SIXTY (60) MINUTES DUE TO A DIFFICULTY IN INSERTING THE END CAP. CONCOMITANT DEVICE REPORTED: EXPERT ANTEGRADE 2 FEMORAL NAIL, (PART # 04.009.352S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) END-CAP F/A2FN CANN EXTENS. 10 TAN GREY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369070 END-CAP F/A2FN CANN EXTENS. 10 TAN GREY ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MEZZOVICO 9940091

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR