BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8020134 · Received October 30, 2018

    Report

    Report Number
    3005985723-2018-00630
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 18, 2018
    Report Date
    January 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    PMA / PMN Number
    K170581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING REVISION FROM PARTIAL KNEE PROCEDURE TO A TOTAL KNEE PROCEDURE INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 588 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 SEGMENTATION FAILURE AFFECTING BONE REGISTRATION. THERE WERE OTHER SIMILAR REPORTED EVENTS FOR THE LISTED CATALOG NUMBER (PR1871551, 1805198, AND 1810094). CONCLUSION: SESSION DATA FROM THE CASE WAS REVIEWED. AREAS OF INVESTIGATION INCLUDED CT LANDMARKS, IMPLANT PLANNING, ARRAY SHIFTS, CUTTING TOOL LOCATION REVIEW, AND BONE REGISTRATION. THE DATA AT THIS TIME SHOWS THAT THE MAKO ROBOTIC ARM OPERATED AS EXPECTED. NO SYSTEM DEFECT OR MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 0

    AFTER COMPLETING ALL OF THE CUTS IN A MAKO TKA, DR. (B)(6) STATED THAT HE PARTIALLY CUT A BIT OF THE ANTERIOR MCL. HE BELIEVES THAT THE CUT HAPPENED WITH THE SIDE OF THE SAWBLADE NOT THE TIP OF IT. IT DID NOT NEGATIVELY IMPACT THE OUTCOME OF THE CASE, AS THE MEDIAL SIDE WAS A LITTLE TIGHT COMPARED TO THE LATERAL SIDE (APPROX 17MM MEDIALLY VS 22MM LATERALLY). CASE TYPE: TKA.

    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

    AFTER COMPLETING ALL OF THE CUTS IN A MAKO TKA, DR. (B)(6) STATED THAT HE PARTIALLY CUT A BIT OF THE ANTERIOR MCL. HE BELIEVES THAT THE CUT HAPPENED WITH THE SIDE OF THE SAW BLADE NOT THE TIP OF IT. IT DID NOT NEGATIVELY IMPACT THE OUTCOME OF THE CASE, AS THE MEDIAL SIDE WAS A LITTLE TIGHT COMPARED TO THE LATERAL SIDE (APPROX 17MM MEDIALLY VS 22MM LATERALLY). CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859613 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other