BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996823 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00143
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    December 29, 2014
    Report Date
    August 7, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO HANDPIECE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR FURTHER EVALUATION. THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION CONFIRMED THE REPORTED EVENT. THE HANDPIECE WAS NOT LOCKING INTO PLACE NOR HOMING AND THIS IS DUE TO THE SNAP LOCK HAVING BEEN BROKEN. THE DRILL CARRIER WAS NOT ATTACHED TO THE REST OF THE SNAP LOCK ASSEMBLY; THUS, THE DRILL HAS NOTHING TO SNAP INTO. FURTHERMORE, WITH THE DRILL NOT BEING EXTENDED/RETRACTED, THE LEAD SCREW NUT WAS ABLE TO MOVE THE FULL LENGTH OF THE LEAD SCREW DURING HOMING THUS EXCEEDING THE EXPECTED RANGE AND TRAVELING THE FULL RANGE. THIS WOULD RESULT IN THE FAILED HOMING. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO BE DUE TO USER ERROR. A DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL SPECIFICATIONS DURING RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTS. THE NAVIOPFS SYSTEM FOR UNICONDYLAR KNEE REPLACEMENT (UKR) USER'S MANUAL RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS ON TOOL POSITIONING FOR HOMING AND HOMING VALIDATION TECHNIQUES. THIS FAILURE IS CAPTURED IN THE NAVIO RISK PROFILE. PER COMPLAINT DETAILS, CURRENTLY UNABLE TO RULE OUT A PROCEDURAL VARIANCE AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT WHICH DOES NOT REPRESENT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE COULD BE CALIBRATED BUT IT DID NOT HOME. THE LONG ATTACHMENT AND BUR WERE DISASSEMBLED AND ASSEMBLED BUT IT DID NOT WORK. ANOTHER HANDPIECE AND DRILL WERE USED BUT THEY DID NOT HOME. THE INSTRUMENTS WERE LUBRICATED BUT IT DID NOT WORK. THE HANDPIECE SEEMED TO NOT HOLD THE DRILL AND LOCK IT. ONE DRILL KEPT SPINNING AND NOT LOCKING, THE OTHER ONE WAS VERY DIFFICULT TO PUSH IN AND LOCK BUT WOULD LOCK. A NEW LONG ATTACHMENT WAS GOING TO BE USED BUT THE TIP WAS SEVERED RIGHT IN HALF CLEAN CUT OFF TIP MAKING IMPOSSIBLE THE USE. THE CASE WAS COMPLETED USING MANUAL INSTRUMENTS. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THE SNAP LOCK ASSEMBLY ON THE HANDPIECE WAS BROKE, WHICH MAKES IT THE ROOT CAUSE OF THE DEVICE MALFUNCTION. PATIENT INJURIES WERE NOT REPORTED BEYOND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461923 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1