BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 7203668 · Received January 18, 2018

    Report

    Report Number
    3005985723-2018-00026
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    December 19, 2017
    Report Date
    March 2, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE END EFFECTOR WAS FOUND TO BE DAMAGED AFTER IT WAS DIFFICULT TO LOCK AFTER THE CASE. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION CONFIRMS FAILED LOCKING MECHANISM. DISCOLORATION AND WEAR IS SEEN ON THE 202862 HIP BALL RETAINER. VISUAL INSPECTION CONFIRMS THE 202857 DOWEL PIN LOCATES THE 206966 REAMER BARREL IS SITTING LOWER THAN EXPECTED. THIS COULD MAKE IT DIFFICULT TO INSERT OR REMOVE INSTRUMENTS FROM THE END EFFECTOR. FRACTURE MARKS ARE ALSO SEEN AT THE DEGREE MARKERS OF THE 206966 REAMER BARREL. VISUAL INSPECTION CONFIRMS A SHEARED OFF 202866 HIP RELEASE KNOB. SEE ATTACHMENTS FOR IMAGES OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION AS NOT COMPLETED AS VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT 19410515 AND (B)(4) INCLUDING S/N (B)(4) ACCEPTED INTO FINAL STOCK ON 08/30/2016. REVIEW OF QT16-08-0108 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 206967, LOT NUMBER 19410515 SHOWS (B)(4) ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. (B)(4). CONCLUSIONS: FAILURE MODE 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.

    Description of Event or Problem · 0

    DR. (B)(6) HAD SOME DIFFICULTY LOCKING THE INLINE-OFFSET IMPACTOR IN THE END EFFECTOR, BUT HE WAS ABLE TO LOCK IT. AFTER THE CASE I LOOKED AND THE SILVER PIECE AT THE END SNAPPED OUT. THA CASE.

    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

    DR. (B)(6) HAD SOME DIFFICULTY LOCKING THE INLINE-OFFSET IMPACTOR IN THE END EFFECTOR, BUT HE WAS ABLE TO LOCK IT. AFTER THE CASE, I LOOKED AND THE SILVER PIECE AT THE END SNAPPED OUT. THA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47905 HIP END EFFECTOR, VARIABLE ANGLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 1901065 / 19410515

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization