BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6146049 · Received December 5, 2016

    Report

    Report Number
    3005985723-2016-00413
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 29, 2016
    Report Date
    January 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: ITEM (PN 206967) BROKE AT COLLAR. DEVICE EVALUATION AND RESULTS: "VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED AS THE VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE." DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND INSPECTED ON 04-05-2016. (B)(4) WERE ACCEPTED WITH NO REPORTED DISCREPANCIES, THIS INCLUDES THE RETURNED DEVICE. (B)(4) WAS DISPOSITIONED ACCORDING TO QT16-04-0015. ADDITIONALLY, THE INSPECTION RECORD CONFIRMS THAT THE CERTIFICATE OF CONFORMANCE FOR ASSEMBLY WAS PRESENT AND ACCURATE FOR ALL TOP AND SUBASSEMBLY COMPONENTS. COMPLAINT HISTORY REVIEW: "BASED ON THE DEVICE IDENTIFICATION, THE (B)(6) COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING THE VARIABLE HIP END EFFECTOR, FAILED LOCKING MECHANISM. THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. THERE HAS BEEN 4 EVENTS REFERENCED FOR THE LOT NUMBER. PRS # (B)(4) - WERE FOUND TO BE FROM THE SAME LOT AS THE PART IN THIS COMPLAINT. THE PARTS FROM PRS # (B)(4) THE SAME FAILURE." CONCLUSIONS: ALLEGED FAILURE CONFIRMED. 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

    DURING THE CASE OF A TOTAL HIP ARTHROPLASTY PROCEDURE, USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE HIP END EFFECTOR BROKE AT COLLAR.

    Description of Event or Problem · 1

    DURING THE CASE OF A TOTAL HIP ARTHROPLASTY PROCEDURE, USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO), THE HIP END EFFECTOR BROKE AT COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796365 HIP END EFFECTOR, VARIABLE ANGLE STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization