BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE CROSS CONNECTOR DRIVER

    MDR report key: 3004686 · Received March 12, 2013

    Report

    Report Number
    3005977257-2013-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 11, 2013
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DAMAGED DRIVER, INVESTIGATION REVEALED THAT IT WAS WITHIN 1 YEAR SERVICE PLAN. REVIEW OF LOT HISTORY REVEALED THAT ALL QUALITY REQUIREMENTS HAD BEEN MET. FIELD REP CONFIRMED THAT THE SURGEON HAD USED A NON-TORQUE LIMITING HANDLE WITH THE DRIVER. THE PEDFUSE SURGICAL TECHNIQUE REQUIRES THAT A 12IN/1B TORQUE LIMITING HANDLE BE USED. SUPPLY CHAIN CONFIRMED THAT THE CORRECT HANDLES HAD BEEN SHIPPED WITH THE SURGICAL KIT. DURING TECHNICAL INSPECTION THE DAMAGED DRIVER WAS COMPARED TO A CONFORMING DRIVER OF THE SAME LOT IN INVENTORY. THE LENGTH OF THE DAMAGED DRIVER WAS LESS THAN THAT OF THE INVENTORY DRIVER, CONFIRMING THAT A PIECE WAS MISSING. FIELD REP INDICATED THAT THE LOCATION OF THE BROKEN DRIVER PIECE WAS UNK. IT COULD HAVE BEEN DISCARDED WITH THE CLEANUP. BECAUSE THIS CANNOT BE CONFIRMED WITHOUT FLUOROSCOPIC IMAGES FROM THE PT, THIS MDR IS BEING FILED TO ADDRESS THE POSSIBILITY THAT THE BROKEN PIECE MAY BE EMBEDDED WITHIN THE SCREW HEAD WITHIN THE PATIENT. FLUOROSCOPIC IMAGES WILL CONFIRM WHETHER OR NOT THE PIECE IS WITHIN THE PATIENT. WE HAVE BEEN AND SHALL CONTINUE TO PURSUE THESE IMAGES FROM THE SURGEON. IF ADD¿L INFO IS ACQUIRED THAT CHANGES OR FURTHER CLARIFIES THE CONTENT OF THIS MDR, AN AMENDMENT TO THE FILE WILL BE SUBMITTED IF NECESSARY.

    Description of Event or Problem · 1

    WHILE SURGICALLY IMPLANTING PEDFUSE SYSTEM INTO A PATIENT, THE SURGEON USED A CROSS CONNECT DRIVER WITH A NON-TORQUE LIMITING HANDLE AND STRIPPED THE DRIVER. THE SURGEON THEN USED A DIFFERENT INSTRUMENT AND SURGERY CONTINUED AS SCHEDULED. THE PART WAS RETURNED AND TECHNICAL INSPECTION SHOED EVIDENCE OF OVER TORQUING AND BREAKAGE. DAMAGED SECTION OF PART WAS NOT THE SAME LENGTH AS DRAWING SPECIFICATIONS; HOWEVER, NO BROKEN PIECE WAS RETURNED. THE FIELD REP CONFIRMED THAT THE LOCATION OF THE BROKEN DRIVER PIECE IS UNK. IT COULD HAVE BEEN DISCARDED WITH THE CLEANUP. BECAUSE THIS CANNOT BE CONFIRMED, THIS MDR IS BEING FILED TO ADDRESS THE POSSIBILITY THAT THE BROKEN PIECE MAY BE EMBEDDED WITHIN THE SCREW HEAD WITHIN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103306 PEDFUSE CROSS CONNECTOR DRIVER CROSS CONNECTOR DRIVER LXH SPINEFRONTIER, INC. 11-80117 012122-002

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other