BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICASSO II

    MDR report key: 16358158 · Received February 10, 2023

    Report

    Report Number
    3009051471-2018-00037
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    July 20, 2018
    Report Date
    February 10, 2023
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THESE DRIVERS WERE RECALLED UNDER 300905147108022018-001-R AND REWORKED FOR INCREASED FUNCTIONALITY. OUT OF ALL THE RECALLED DEVICES, THE LOT 7EQBB-C HAD 6 OF THE DRIVERS MALFUNCTION. THIS SUBMISSION WAS PREVIOUSLY SUBMITTED TO THE FDA UNDER MDR-3009051471-2011-00020. THIS WAS A TYPO AND THE SUBMISSION NUMBER SHOULD HAVE READ MDR-3009051471-2018-00020. IN THIS SUBMISSION, SIX (6) PEDICLE SCREW DRIVERS WERE SUBMITTED UNDER A SINGLE SUMMARY REPORT. THE REGULATION FOR SUMMARY REPORTS WAS RELEASED LATER THAN THE INCIDENT AWARENESS DATE NOT PERMITTING THAT THESE DRIVERS BE GROUPED UNDER THE SUMMARY REPORT. THESE DRIVER REPORTS WERE THEN SEPARATED OUT INTO SEPARATE MDR SUBMISSIONS WITH IDENTICAL INCIDENT INFORMATION AS REQUIRED BY THE FDA. THIS SUBMISSION SERVES AS THE FIRST OF THE CORRECTED SUBMISSIONS REQUESTED BY THE FDA. MDR-3009051471-2018-00020-01 IS THE FDA REQUESTED FOLLOW-UP AND WILL SERVE AS THE FIRST SUBMISSION OUT OF THE 6 REQUIRED. THE FOLLOWING SUBMISSION NUMBERS ARE IN RESPONSE TO THESE (5) REQUIRED SUBMISSIONS AND ARE REPRESENTED BELOW: 3009051471-2018-00020-01, 3009051471-2018-00034, 3009051471-2018-00035, 3009051471-2018-00036 AND 3009051471-2018-00038.

    Description of Event or Problem · 0

    THERE WAS NO HARM NOR INJURY TO THE PATIENT. PEDICLE SCREW DRIVERS WERE RETURNED FROM THE FIELD WITH THE DISTAL ANTI-TOGGLE RING SEPARATED FROM (6) DRIVERS. THESE PARTS WERE RETURNED TO THE WITHOUT A DESCRIPTION OF INCIDENT AND IT IS UNKNOWN THAT THESE WERE USED IN SURGERY. THE ANTI-TOGGLE RING IS MEANT TO INTERFACE WITH THE PEDICLE SCREW HEAD DURING INSERTION TO IMPROVE STABILITY. THIS RING WAS ASSEMBLED WITH THE DRIVER USING A HIGH STRENGTH EPOXY RESIN. INTERNAL TESTING WAS COMPLETED AND RESULTED IN THE AVERAGE LOADING FORCE TO BE 1070N, AS WAS DEEMED AS SUFFICIENT, AS THIS FORCE EXCEEDS CLINICAL LOADS SEEN DURING IMPLANTATION. ADDITIONAL BENCH TOP TESTING WAS CONDUCTED, AND THERE IS SPECULATION THAT WITH OFF-ANGLE INSERTION INTO THE SCREW HEAD WITH EXCESSIVE FORCE THAT COULD CAUSE THIS ANTI-TOGGLE RING TO SEPARATE FROM THE PROXIMAL SHAFT. THE TESTING CONDUCTED COULD NOT REPLICATE ANY OF THE OBSERVED SEPARATIONS. DUE TO LACK OF INFORMATION PROVIDED (I.E. LACK OF IMAGES PROVIDED [PRE-OPERATIVE AND POST OPERATIVE], PATIENT ANATOMY, AND SURGICAL TECHNIQUE USED), THIS EVENT IS DEEMED INDETERMINATE. AS A PROACTIVE MITIGATION ACTION, THE DRIVER ASSEMBLY WAS UPDATED TO HAVE THE ANTI-TOGGLE RING BE LASERWELDED TO THE MAIN DRIVER SHAFT. THIS WELD ALLOWS FOR THE AVERAGE LOADING FORCE TO BE INCREASED BY 2.5 TIMES THAT TO THE EPOXY RESIN THAT WAS ORIGINALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47673 PICASSO II DRIVER LXH CTL MEDICAL CORPORATION 019.7050 7EQBB-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown