BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPCI MOTION CONTROL ASSEMBLY 3.0

    MDR report key: 8020127 · Received October 30, 2018

    Report

    Report Number
    3005985723-2018-00631
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 24, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS (B)(6) REPORTED BURR STATUS MISMATCH ERROR; TKA. DEVICE EVALUATION AND RESULTS: PER (B)(4): (B)(6) DEMONSTRATED THAT WHEN EVER THE TRIGGER WAS PULLED ON THE MICS HANDPIECE THE MICS WOULD RUN. I REPLACED THE CUTTER ASSEMBLY AND THE PROBLEM WAS STILL THERE. I REPLACED THE CPCI ASSY AND DID A COMPLETE CHECKOUT PER THE FOLLOW UP MATRIX ON IN THE MANUAL. THE OLD CPCI IS P/N 211123, LOT NUMBER 2111231-1. THE NEW CPCI IS 209953-R, LOT NUMBER 058980. JAVIN DID A COMPLETE CHECK WITH THE SAWBONES. HE IS SATISFIED THE ROBOT IS READY. I DID A COMPLETE CHECK WITH NO ERRORS OR PROBLEMS. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 12/11/09 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 09-11-0049, NPR 09-12-0035, NPR 09-12-0083, NPR 09-11-0081, NPR 09-11-0111, NPR 09-10-0003, NPR 09-10-0138, NPR 09-10-0025, NPR 09-11-0034. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209953 SHOWS 9 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    (B)(4): MPS (B)(6) REPORTED BURR STATUS MISMATCH ERROR; TKA. RESOLUTION: (B)(6) DEMONSTRATED THAT WHEN EVER THE TRIGGER WAS PULLED ON THE MICS HANDPIECE THE MICS WOULD RUN. I REPLACED THE CUTTER ASSEMBLY AND THE PROBLEM WAS STILL THERE. I REPLACED THE CPCI ASSY AND DID A COMPLETE CHECKOUT PER THE FOLLOW UP MATRIX ON IN THE MANUAL. THE OLD CPCI IS P/N 211123, LOT NUMBER 2111231-1. THE NEW CPCI IS 209953-R, LOT NUMBER 058980. (B)(6) DID A COMPLETE CHECK WITH THE SAWBONES. HE IS SATISFIED THE ROBOT IS READY. I DID A COMPLETE CHECK WITH NO ERRORS OR PROBLEMS UPDATE: DELAY WAS >30 MINS. CASE WAS CONVERTED TO MANUAL. PATIENT WAS UNDER ANESTHESIA.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(6): MPS (B)(6) REPORTED BURR STATUS MISMATCH ERROR; TKA. RESOLUTION: (B)(6) DEMONSTRATED THAT WHEN EVER THE TRIGGER WAS PULLED ON THE MICS HANDPIECE THE MICS WOULD RUN. I REPLACED THE CUTTER ASSEMBLY AND THE PROBLEM WAS STILL THERE. I REPLACED THE CPCI ASSY AND DID A COMPLETE CHECKOUT PER THE FOLLOW UP MATRIX ON IN THE MANUAL. THE OLD CPCI IS P/N 211123, LOT NUMBER 2111231-1. THE NEW CPCI IS 209953-R, LOT NUMBER 058980. (B)(6) DID A COMPLETE CHECK WITH THE SAWBONES. HE IS SATISFIED THE ROBOT IS READY. I DID A COMPLETE CHECK WITH NO ERRORS OR PROBLEMS. UPDATE: DELAY WAS >30 MINS. CASE WAS CONVERTED TO MANUAL. PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859606 CPCI MOTION CONTROL ASSEMBLY 3.0 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT 058980 2111231-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization