BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE SYSTEM

    MDR report key: 16313594 · Received February 7, 2023

    Report

    Report Number
    3006179046-2023-00110
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Report Date
    April 17, 2023
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00812258020286
    PMA / PMN Number
    K191336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: UPON RECEIPT OF THE RETURNED DEVICE, VISUAL INSPECTION REVEALED THE HOUSING TUBE WAS BENT IN THE MIDDLE. THE BENT HOUSING TUBE MAY HAVE IMPACTED THE PERFORMANCE OF THE NAIL AND LIKELY RESULTED IN FAILURE DURING USE. THE REPORTED FAILURE HAS THEREFORE BEEN CONFIRMED. THE X-RAY IMAGES (TAKEN UPON RETURN) ALSO CONFIRMED THE BENDING OF THE HOUSING TUBE. THE X-RAY INSPECTION REVEALED NO OTHER INTERNAL FAILURE OR BROKEN COMPONENT. THE NAIL WAS FUNCTIONALLY TESTED AND WAS UNABLE TO DISTRACT AND RETRACT WITH THE EXTERNAL REMOTE CONTROLLER (ERC) AND HIGH-SPEED MAGNET. THE UNIT HAS BEEN DETERMINED TO HAVE BEEN JAMMED DUE TO THE HOUSING TUBE BENDING. THE BENDING OF THE HOUSING TUBE CAUSED THE INTERNAL COMPONENTS OF THE UNIT TO BECOME MISALIGNED WHICH MAY HAVE LED TO THE JAMMING. THE UNIT DID NOT PASS THE FUNCTIONAL TESTING SPECIFICATION. THE INSPECTION DATA FOR THE LOT OF THE HOUSING TUBE (LOT #210325-10) HAS BEEN REVIEWED AND CONFIRMS THE PART MET DESIGN SPECIFICATIONS PER THE ENGINEERING DRAWING. BASED ON THE PROVIDED INFORMATION FROM THE PHYSICIAN, AS WELL AS THE TYPE OF BEND OBSERVED IT IS LIKELY THAT THE NAIL BECAME BENT AS A RESULT OF STRESS GENERATED FROM PATIENT WEIGHT BEARING ACTIVITIES. IF EXCESS STRESS OR FORCE WAS APPLIED TO THE NAIL DUE TO WEIGHT-BEARING ACTIVITIES, IT'S POSSIBLE THAT THIS CONTRIBUTED TO THE BENDING OF THE HOUSING TUBE. THE NAIL IS DESIGNED TO WITHSTAND CERTAIN LEVELS OF STRESS AND FORCE, BUT IF IT IS SUBJECTED TO EXCESSIVE AMOUNTS, IT MAY BECOME DAMAGED OR BENT. DEVICE LABELING: PER THE PRECICE INSTRUCTIONS FOR USE, "THE PRECICE INTRAMEDULLARY LIMB LENGTHENING NAIL CANNOT WITHSTAND THE STRESSES OF FULL WEIGHT BEARING FOR TIBIA AND FEMUR APPLICATIONS. PATIENTS SHOULD UTILIZE EXTERNAL SUPPORT, AND/OR RESTRICT ACTIVITIES AS DIRECTED BY THE PHYSICIAN UNTIL CONSOLIDATION OCCURS". DEVICE RECORDS REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) CONFIRMED THE DEVICE MET ALL QUALITY INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BELIEVES THERE IS A PROBLEM WITH THE NAIL BECAUSE WHEN THEY USED THE ELECTRONIC REMOTE CONTROLLER (ERC) TO DISTRACT IT MAKES A NOISE. THE ISSUE LED TO A DIFFERENCE IN DISTRACTION FROM THE OPPOSITE SIDE NAIL. UPON COMPLETING DISTRACTION DURING FOLLOW UP WITH THE PHYSICIAN, THEY FOUND THAT THE NAIL IS BENT ON THE SIDE THAT MADE THE NOISE. THE NAIL WAS EXPLANTED AND EXCHANGED FOR AN INTERLOCKING NAIL. THE PATIENT WAS REPORTED TO HAVE BEEN FULL WEIGHT BEARING BEYOND THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926764 PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. P10.7-80B335 1062301AAA 00812258020286

    Patients

    Seq Age Sex Outcome Treatment
    1 Male