BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINLAB KNEE NAVIGATION SYSTEM (BONE FIXATOR)

    MDR report key: 2823661 · Received October 31, 2012

    Report

    Report Number
    8043933-2012-00019
    Event Type
    Other
    Date Received
    October 31, 2012
    Date of Event
    May 17, 2010
    Report Date
    September 10, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    OLO
    PMA / PMN Number
    K102990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. THE BRAINLAB DEVICE WORKS AS INTENDED. THE ACCORDING BRAINLAB MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. A RISK OF THESE PT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. FOLLOWING THE ASSESSMENT FROM THE RESPONSIBLE SURGEON, THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS THAT THE SCHANZ PINS WERE INSERTED TOO DEEP AND INJURED THE NERVE TO EHL. THE SCHANZ SCREWS IN QUESTION ARE NOT A BRAINLAB DEVICE, HOWEVER THEY ARE DISTRIBUTED BY (B)(4) FOR THE USE WITH BRAINLAB NAVIGATION AND IN THESE CASES HAVE BEEN SPECIFICALLY USED TO ENABLE NAVIGATION OF THE BRAINLAB DEVICE. THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. THE ACCORDING MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. BRAINLAB INTENDS TO OFFER ADDITIONAL TRAINING TO THIS HOSPITAL. BRAINLAB WAS MADE AWARE OF THE ALLEGED SERIOUS INJURY ON 10/22/2012.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. THE BRAINLAB DEVICE WORKS AS INTENDED. THE ACCORDING BRAINLAB MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. A RISK OF THESE PT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. FOLLOWING THE ASSESSMENT FROM THE RESPONSIBLE SURGEON, THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS THAT THE SCHANZ PINS WERE INSERTED TOO DEEP AND INJURED THE NERVE TO EHL. THE SCHANZ SCREWS IN QUESTION ARE NOT A BRAINLAB DEVICE, HOWEVER THEY ARE DISTRIBUTED BY (B)(4) FOR THE USE WITH BRAINLAB NAVIGATION AND IN THESE CASES HAVE BEEN SPECIFICALLY USED TO ENABLE NAVIGATION OF THE BRAINLAB DEVICE. THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE. THE ACCORDING MEASURES TO REDUCE THIS ALREADY ANTICIPATED RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. BRAINLAB INTENDS TO OFFER ADDITIONAL TRAINING TO THIS HOSPITAL. BRAINLAB WAS MADE AWARE OF THE ALLEGED SERIOUS INJURY ON 10/22/2012.

    Description of Event or Problem · 1

    BRAINLAB RECEIVED INFO FROM THE HOSPITAL, REPORTING THE FOLLOWING FOR 4 DIFFERENT PATIENTS: THE PTS RECEIVED A TOTAL KNEE REPLACEMENT WITH THE AID OF THE BRAINLAB KNEE NAVIGATION SYSTEM. AFTER THE SURGERY THE PTS HAD A WEAKNESS IN THEIR EXTENSOR HALLUCIS LONGUS MUSCLE (EHL), RESULTING IN INABILITY TO EXTEND THEIR BIG TOE. TO BE ABLE TO USE THE BRAINLAB NAVIGATION AN ACCORDING REFERENCE ARRAY HAS TO BE AFFIXED TO THE TIBIAL AND FEMORAL BONE VIA SCHANZ SCREWS. THE SCREWS ARE REMOVED AFTER THE PROCEDURE. THE SURGEON ALLEGES THAT THE ROOT CAUSE FOR THE WEAKNESS IS, THAT THE TIBIAL SCHANZ SCREW, THAT IS USED TO ATTACH THE NAVIGATION REFERENCE ON THE PT'S TIBIA, HAS BEEN INSERTED TOO DEEP. CLINICAL OUTCOME FOR PT ACCORDING TO HOSPITAL: (DATE OF EVENT: (B)(6) 2010: FULL RECOVERY.

    Description of Event or Problem · 1

    BRAINLAB RECEIVED INFO FROM THE HOSPITAL, REPORTING THE FOLLOWING FOR 4 DIFFERENT PATIENTS: THE PTS RECEIVED A TOTAL KNEE REPLACEMENT WITH THE AID OF THE BRAINLAB KNEE NAVIGATION SYSTEM. AFTER THE SURGERY THE PTS HAD A WEAKNESS IN THEIR EXTENSOR HALLUCIS LONGUS MUSCLE (EHL), RESULTING IN INABILITY TO EXTEND THEIR BIG TOE. TO BE ABLE TO USE THE BRAINLAB NAVIGATION AN ACCORDING REFERENCE ARRAY HAS TO BE AFFIXED TO THE TIBIAL AND FEMORAL BONE VIA SCHANZ SCREWS. THE SCREWS ARE REMOVED AFTER THE PROCEDURE. THE SURGEON ALLEGES THAT THE ROOT CAUSE FOR THE WEAKNESS IS, THAT THE TIBIAL SCHANZ SCREW, THAT IS USED TO ATTACH THE NAVIGATION REFERENCE ON THE PT'S TIBIA, HAS BEEN INSERTED TOO DEEP. CLINICAL OUTCOME FOR PT ACCORDING TO HOSPITAL: PT 1 (DATE OF EVENT: (B)(6) 2010): FULL RECOVERY. PT 2 (DATE OF EVENT: (B)(6) 2010): FULL RECOVERY AFTER SURGICAL INTERVENTION. PT 3 (DATE OF EVENT: (B)(6) 2011): RECOVERY UNLIKELY. PT 4 (DATE OF EVENT (B)(6) 2012): NO RECOVERY YET, POTENTIAL TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB KNEE NAVIGATION SYSTEM (BONE FIXATOR) IMAGE GUIDED SURGERY SYSTEM/STEREOT OLO BRAINLAB AG 52420A NA

    Patients

    Seq Age Sex Outcome Treatment
    1