BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 7074229 · Received December 1, 2017

    Report

    Report Number
    3005985723-2017-00594
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 20, 2017
    Report Date
    March 2, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING ANTERIOR SLOPE ON TIBIAL CUT INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH (B)(4) FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING SAW BLADE VERIFICATION FAILURE. THERE WAS ONE OTHER REPORTED EVENT FOR THE LISTED PART NUMBER ((B)(4)). CONCLUSION: DEVICE INSPECTION COULD NOT BE PERFORMED; VPLOGS WERE PROVIDED BUT SESSION DATA WAS NOT PROVIDED. THREE COMMUNICATION ATTEMPTS WERE MADE. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED. SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. LOGS WERE PROVIDED: (B)(6). PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED. PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED.

    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

    PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED. SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. LOGS WERE PROVIDED: (B)(6):(B)(6) 2017_DR. (B)(6). PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED. PRIOR TO BONE RESECTION DURING MAKO TKA PROCEDURE, SURGEON PLACED GREEN PROBE ON ANGLED SAW BLADE TO VERIFY CHECKPOINT AND RECEIVED A MEASUREMENT GREATER THAN 2MM. SURGEON WAS INSTRUCTED TO CHANGE THE POSITION OF THE GREEN PROBE AND BRING THE SAW BLADE CLOSER TO THE INCISION. BLADE CHECKPOINT PASSED AUTOMATICALLY AND SURGEON PROCEEDED TO MAKE DISTAL CUT. SURGEON SUSPECTED DISTAL FEMORAL CUT WAS MORE THAN PLANNED AND CHECKED THE CUT WITH THE PLANAR PROBE AND GREEN PROBE. THE PLANAR AND GREEN PROBE SHOWED THE DISTAL CUT TO BE 1MM DEEP ON THE LATERAL CONDYLE AND UP TO 2MM DEEP ON THE MEDIAL CONDYLE. THE MAKO SYSTEM WAS RE-REGISTERED AND THE REST OF THE FEMORAL AND TIBIAL CUTS WERE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854527 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization