BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV L INSERTION INSTRUMENT F/H10MM

    MDR report key: 6216581 · Received December 30, 2016

    Report

    Report Number
    9610612-2016-00013
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 22, 2016
    Report Date
    April 30, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    MJO
    PMA / PMN Number
    P120024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX 600 D DIGITAL MICROSCOPE. PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL AND MICROSCOPIC INVESTIGATION OF THE INSTRUMENT. HERE WE FOUND THAT ONE OF THE CAUDAL SIDE WAS BENT. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE IS MOST PROBABLY USAGE/HANDLING RELATED. RATIONAL: THE MANUFACTURING DOCUMENTS ARE WITHOUT HINTS OF DEVIATION TO THE PRODUCT SPECIFICATION. A MATERIAL DEFECT OR A MANUFACTURING ERROR CAN BE EXCLUDED. WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES, WE ASSUME A DAMAGE DURING THE STERILIZATION PROCESS OR A HANDLING ERROR. NO CAPA IS NECESSARY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT DURING A LUMBAR DISC REPLACEMENT (A ACTIVE-L PROCEDURE) ON A LEVEL L5/S1. THE IMPLANT CAME APART FOUR TIMES DURING THE INSERTION PROCESS, REQUIRING A RE-ASSEMBLE TO THE IMPLANT EACH TIME. THE SURGEON USED A L-5 INFERIOR PLATE AND A L-6 SUPERIOR PLATE ALONG WITH A 10MM INLAY. AFTER THE IMPLANT WAS ATTACHED IT APPEARED THAT THE DEVICE WAS NOT TIGHTENED SECURELY. USING A TOMMY BAR THE DEVICE WAS TIGHTENED AGAIN, BUT IT STILL DID NOT WORK. THE FOLLOWING STEPS WERE PERFORMED: CHECKED THE PROPER CONFIGURATION ON THE INSERTER. 10MM SHAFT, 10MM INSERT, 10MM CAP ALL CONFIRMED CORRECT. MADE SURE THERE WASN'T ANYTHING OBSTRUCTING THE THREADS ON THE SHAFT OF THE INSERTER. MADE SURE THE ORIENTATION OF THE DEVICE ON THE INSERTER WAS CORRECT, STARTED TO OPEN ANOTHER PAIR OF LARGE, L5/S1 ENDPLATES. AFTER OPENING THE SUPERIOR PLATE, DOCTOR (SURGEON) INSISTED ON TRYING ONE MORE TIME. ON THE 5TH ATTEMPT, HE WAS ABLE TO GET IT STARTED IN BETWEEN L5 AND S1 AND DRIVE IT INTO PERFECT PLACEMENT. THE SET WAS EXAMINED AFTER IT WAS CLEARED (CLEANED) AND COULD NOT FIND ANYTHING VISIBLY WRONG WITH THE 10MM INSERTER ASSEMBLE. THERE WAS NO HARM TO THE PATIENT REPORTED. THERE WAS A 15-30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865836 ACTIV L INSERTION INSTRUMENT F/H10MM SPINAL IMPLANT INSERTER MJO AESCULAP IMPLANT SYSTEMS FW962R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other