BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 5461363 · Received February 25, 2016

    Report

    Report Number
    3005985723-2016-00070
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: CUSTOMER REPORTED THAT THE REAR KNOB THAT PULLS BACK TO ENGAGE OR DISENGAGE THE REAMER AND IMPACTOR SHAFTS BROKE OFF. DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE VARIABLE HIP END EFFECTOR EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 06-26-2014 WITH NO REPORTED DISCREPANCIES. 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: A REVIEW OF THE (B)(6) COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING LOCKING MECHANISM FAILURE OF CATALOG: 206967, SERIAL NUMBER: (B)(4), LOT #: 19060214, RMA #: (B)(4). CONCLUSIONS: THE EXACT CAUSE OF THE EVENT WAS: THE VARIABLE HIP END EFFECTOR SHOWED A FAILED LOCKING MECHANISM. SPECIFICALLY THE LOCKING MECHANISM KNOB WAS BROKEN, WHICH HAS MADE ACTUATING THE LOCKING MECHANISM DIFFICULT. THE DEVICE WAS TESTED WITH A 202866 RELEASE KNOB, WHICH DID NOT FULLY SEAT IN HIP EE S/N: (B)(4). THIS INDICATED THAT THE THREADS OF THE PREVIOUS RELEASE KNOB, WHICH BROKE OFF, WERE STILL THERE. THERE WAS ALSO SIGNS OF OXIDATION, WHICH CAN ADD TO THE DIFFICULTY OF ACTUATING THE LOCKING MECHANISM. CORRECTIVE ACTION/PREVENTIVE ACTION: AS THE EVENT DID NOT INVOLVE A MANUFACTURING RELATED PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND, OR UNANTICIPATED HAZARD, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. TREND REQUEST #(B)(4) HAS BEEN INITIATED TO CONTINUE TO MONITOR FOR EVENTS RELATED TO THIS DEVICE.

    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

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) . IT WAS NOTED THAT THE BACK OF THE HIP END EFFECTOR HANDLE BROKE. THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) . IT WAS NOTED THAT THE BACK OF THE HIP END EFFECTOR HANDLE BROKE. THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118138 HIP END EFFECTOR, VARIABLE ANGLE STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other