BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE, NAVIO (BBT HANDPIECE)

    MDR report key: 9996812 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00142
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    December 29, 2014
    Report Date
    August 25, 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

    H10: THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. THE PROBABLE CAUSE OF THE ISSUE WAS A MECHANICAL COMPONENT FAILURE. DHR REVIEW FOUND THAT NO CONDITIONS WHICH COULD CONTRIBUTE TO THE REPORTED EVENT WERE IDENTIFIED. THIS INFORMATION IS REASONABLY SUGGESTING THAT THE DEVICE MET THE SPECIFICATIONS AT THE DATE WHEN IT WAS RELEASED TO THE DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND A SIMILAR REPORT AS THIS WAS THE ONLY COMPLAINT FOR THE REPORTED ISSUE, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE RELEASED AT THE TIME OF THE COMPLAINT PROVIDES INSTRUCTIONS FOR USING THE HANDPIECE. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED. THE INITIAL VISUAL/FUNCTIONAL INVESTIGATION FOUND THAT: HANDPIECE A (B)(6) REPORTEDLY WAS NOT LOCKING INTO PLACE NOR HOMING. 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 HAD 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 (10.925MM) AND TRAVELING THE FULL RANGE (~14.26MM). THIS WOULD RESULT IN THE FAILED HOMING. THE MALFUNCTION IS LIKELY DUE TO MECHANICAL COMPONENT FAILURE FROM BENDING OF THE HANDPIECE DRILL GUIDE SUPPORT. THE MATERIAL HAS BEEN CHANGED TO STAINLESS STEEL TO INCREASE DURABILITY AND REDUCE DEFORMATION IN THE FIELD. 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. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE CHANGE/SUBSEQUENT MODIFIED PROCEDURE, AND THE REPORTED DELAY DID NOT RESULT IN PATIENT INJURY/IMPACT; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME.

    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 INVESTIGATION HAVE CONCLUDED THAT THE DRILL GUIDE SUPPORT ON THE HANDPIECE WAS BENT, 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
    461706 HANDPIECE, NAVIO (BBT HANDPIECE) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1