BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKOPLASTY® PARTIAL KNEE END EFFECTOR

    MDR report key: 5771248 · Received July 5, 2016

    Report

    Report Number
    3005985723-2016-00211
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: END EFFECTOR, PART NUMBER : 111758, SERIAL SN (B)(4). DESCRIPTION: END EFFECTOR MAGNET FOR ANSPACH CAME DETACHED AND CAUSED BURR TO NOT WORK. NOTICED 6/14. NO PATIENT INVOLVEMENT. NO PATIENT HARM. DELAY LESS THAN 15 MINUTES IN CASE TO SWITCH TO FOOT PEDAL CONTROL INSTEAD OF HAND PIECE NO INTERVENTION. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: ALLEGED FAILURE WAS THAT THE 111725 EE2 MAGNET HAD DISASSEMBLED FROM THE 111758 PARTIAL KNEE END EFFECTOR. PARTIAL KNEE END EFFECTOR, P/N 111758, LOT 19330515, S/N (B)(4) RMA 231291 WAS RECEIVED WITH THE 111725 EE2 MAGNET ASSEMBLED. VISUAL INSPECTION COULD NOT CONFIRM ALLEGED FAILURE. SEE ATTACHMENT 1 FOR AN IMAGE OF THE INSTRUMENT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED DUE TO THE NATURE OF THE COMPLAINT BEING RELATED TO VISUAL AND FUNCTIONALITY. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION SHOWS COULD NOT REPLICATE ALLEGED FAILURE OF 111725 EE2 MAGNET DISASSEMBLING FROM THE 111758 PARTIAL KNEE END EFFECTOR. THE 111758 PARTIAL KNEE END EFFECTOR FUNCTIONED AS EXPECTED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK INCLUDING SERIAL NUMBER (B)(4) ON 02/20/2016. QT16-03-0076 WAS GENERATED TO SCRAP SN (B)(4) FROM LOT 19330515 DUE TO VISUAL NON-CONFORMANCE (¿NICKS ON THE BOTTOM ROUND EDGE¿S SURFACE WHERE PART MOUNTS¿) . COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 111758, LOT NUMBER 19330515, S/N (B)(4) SHOWS ZERO COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE PARTIAL KNEE END EFFECTOR, P/N 111758 WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST (B)(4). CONCLUSIONS: ALLEGED FAILURE COULD NOT BE REPLICATED. 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

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE END EFFECTOR MAGNET FOR ANSPACH CAME DETACHED. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE END EFFECTOR MAGNET FOR ANSPACH CAME DETACHED. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422407 MAKOPLASTY® PARTIAL KNEE END EFFECTOR STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other