BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIS IMPLANT INSERTER

    MDR report key: 3132869 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02362
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NO IRREGULARITIES WERE FOUND DURING DEVICE HISTORY RECORD REVIEW. ONE OF THE INSERTERS IS TOTALLY RUSTED AT THE TIP. THE OTHER INSERTER IS RUSTED AT THE TIP TOO, BUT NOT THAT HEAVILY. OTHERWISE THE INSERTERS APPEAR TO BE IN GOOD CONDITION. THE MATERIAL IS CORRESPONDING TO THE SPECIFICATIONS AND WAS SUPPLIED AT THE 21ST OF FEBRUARY 2012 WITH THE LOT 129127. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 44 HRC AND WAS FOUND TO BE GOOD. THE REPROCESSING TEST ACCORDING TO SE_093680 FOR THE FAI TOOK PLACE ON 03.841.050 FOR LOT T965803 AND PASSED. THE DOCUMENTS OF BOTH DELIVERIES FROM LOT T965803 AND LOT T972958 WERE REVIEWED AND NO IRREGULARITIES WERE FOUND. THE RETURN INCLUDES TWO IMPLANT INSERTERS (03.841.050). ONE OF THE INSERTERS IS MISSING THE CLAMP COMPONENT (SE_369606). THE DISTAL END OF THE SLEEVE COMPONENT (SE_382582) DOES SHOW SOME MINOR DISCOLORATION. THE INSTRUMENTS ARE IN EXCELLENT CONDITION. THE ACIS CERVICAL SPACER SYSTEM INCLUDES 2 IMPLANT INSERTERS (03.840.050) TO INSERT OR REMOVE SPACERS. THE CHU REVIEWED THE RELATIVE DRAWINGS FOR THIS INSTRUMENT (SE_369606_1 REV E, SE_382582_1 REV C, SE_388494 REV E, SE_388486_1 REV F, AND SE_369379_1 REV F). THESE DRAWINGS DETAIL THE APPROPRIATE MATERIAL, DIMENSIONS, AND FINISHING PROCESSES. THE COMPLAINT DESCRIBES ROUNDED OFF ON THE TIPS. THE RETURNED CLAMP AND SLEEVE COMPONENTS APPEAR TO BE FABRICATED AS DETAILED IN DRAWINGS SE_388486_1 AND SE_382582_1 RESPECTIVELY. IN ADDITION THE SE_369379_1 DETAILS THE LONGRUN COATING FOR THE DISTAL COMPONENT OF THE SLEEVE SE_382582_1. THE COMPLAINT DESCRIBES THE INSTRUMENTS AS RUSTED. THE MINOR DISCOLORATION DOES NOT APPEAR TO BE RUST. THE DISCOLORATION MAY BE DUE TO UNCLEAN PART PRIOR TO COATING. THE CHU ENGINEER DISASSEMBLED AND ASSEMBLED BOTH INSTRUMENTS AS INTENDED. THE INSTRUMENTS FUNCTIONED AS INTENDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    CONSULTANT REPORTED DURING AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2013, USING THE NEW ANTERIOR CERVICAL INTERBODY SPACER (ACIS) SET, TWO IMPLANT INSERTERS WERE FOUND TO BE ROUNDED OFF ON THE TIPS, AND WERE REPORTEDLY RUSTED. THE SET IS NEW, AND NOT WORN OUT. THE SURGEON DID NOT USE EITHER OF THE COMPLAINED IMPLANT HOLDERS. THEY WERE REMOVED FROM THE SET AND FROM THE OR. THE SURGEON USED A FORCEPS FROM THE PREPARED SURGICAL TRAY IN THE OR TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, AND NO EXTENSION OF SURGERY TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236298 ACIS IMPLANT INSERTER LXH SYNTHES GMBH T972958

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR