BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6269731 · Received January 23, 2017

    Report

    Report Number
    3005985723-2017-00029
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    December 14, 2016
    Report Date
    February 13, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    "REPORTED EVENT: IT WAS REPORTED THAT THE HANDLE SCREW FELL OUT. ISSUE WAS NOTICED DURING A CASE AND THERE WAS UNKNOWN CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K08KV AND (B)(4) INCLUDING 4201223 WERE ACCEPTED INTO FINAL STOCK ON 11/12/2016." "VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS WITH THE SCREW AND HANDLE. A REVIEW OF COMPLAINTS RELATED TO P/N 209063 SHOWS 8 OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION (INVESTIGATIONS (B)(4)). ISSUES FOR P/N 209063 WILL BE TRACKED THROUGH TREND REQUEST #1025. CONCLUSIONS: THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL. 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 · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). -WHEN GOING IN TO MAKE TIBIA CUT, THE TIBIA ARRAY FELL DOWN. I PHYSICALLY WATCHED HIM TIGHTEN IT INITIALLY SO I THINK THE ISSUE MAY HAVE BEEN THAT HE DID NOT ENSURE THE TEETH WERE INTERDIGITATED BEFORE TIGHTENING. LUCKILY WE HAD NOT CUT, SO HE WAS EASILY ABLE TO RECOVER, ERASE EVERYTHING AND RE-REGISTER THE TIBIA. -REGISTRATION PAGE WAS FROZEN WHEN WE WENT BACK IN BUT HE WAS STILL ABLE TO COMPLETE THE STEP. -AFTER CUTTING THE TIBIA THE PA FOUND A SCREW ON THE OPERATING ROM TABLE, WE LATER FOUND OUT THAT IT HAD FALLEN OUT OF THE BOTTOM OF THE MICS BUT THE HANDLE NEVER CAME DETACHED.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). WHEN GOING IN TO MAKE TIBIA CUT, THE TIBIA ARRAY FELL DOWN. I PHYSICALLY WATCHED HIM TIGHTEN IT INITIALLY SO I THINK THE ISSUE MAY HAVE BEEN THAT HE DID NOT ENSURE THE TEETH WERE INTERDIGITATED BEFORE TIGHTENING. LUCKILY WE HAD NOT CUT, SO HE WAS EASILY ABLE TO RECOVER, ERASE EVERYTHING AND RE-REGISTER THE TIBIA. REGISTRATION PAGE WAS FROZEN WHEN WE WENT BACK IN BUT HE WAS STILL ABLE TO COMPLETE THE STEP AFTER CUTTING THE TIBIA THE PA FOUND A SCREW ON THE OR TABLE, WE LATER FOUND OUT THAT IT HAD FALLEN OUT OF THE BOTTOM OF THE MICS BUT THE HANDLE NEVER CAME DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53716 HANDPIECE MICS STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization