BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6 ARM FOR HIP WITH QD

    MDR report key: 6074217 · Received November 2, 2016

    Report

    Report Number
    3005985723-2016-00357
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    November 1, 2016
    Report Date
    April 21, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 IS BEING SUBMITTED TO CORRECT/UPDATE (PRODUCT DESCRIPTION AND LOT#).

    Additional Manufacturer Narrative · 1

    DEVICE IDENTIFICATION: THE REPORTED DEVICE WAS CONFIRMED TO BE A J6 ARM FOR HIP WITH QD, P/N 207557, LOT ROB234. DEVICE HISTORY REVIEW: A DHR REVIEW SHOWS THAT THE ROBOT THAT INCLUDES THIS COMPONENT WAS ASSEMBLED AND RELEASED TO INVENTORY ON 1/23/2013. DEVICE EVALUATION AND RESULTS: ACCORDING TO GSP CASE (B)(4), THE FAILURE WAS CONFIRMED, AND WAS BEING CAUSED BY DEBRIS ON THE J6 ENCODER GLASS. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 207557 ON ROB234 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. 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.

    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

    WHILE THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE ROBOT WOULD NOT PASS "CUBE" DURING THE RIO REGISTRATION. THE SURGEON PROCEEDED BY COMPLETING THE CASE MANUALLY.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE ROBOT WOULD NOT PASS "CUBE" DURING THE RIO REGISTRATION. THE SURGEON PROCEEDED BY COMPLETING THE CASE MANUALLY.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE ROBOT WOULD NOT PASS "CUBE" DURING THE RIO REGISTRATION. THE SURGEON PROCEEDED BY COMPLETING THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723560 J6 ARM FOR HIP WITH QD STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. ROB 234

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization