BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY RIO REGISTRATION

    MDR report key: 5352201 · Received January 7, 2016

    Report

    Report Number
    3005985723-2016-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE IDENTIFICATION: THE REPORTED DEVICE WAS CONFIRMED TO BE AN ARRAY RIO REGISTRATION, P/N 160230, LOT# 19120214. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE INSPECTED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES; (B)(4) ON (B)(6) 2014, AND (B)(4) ON (B)(6) 2014. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 160230, LOT NUMBER 06120412 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 160230 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST # (B)(4). CONCLUSIONS: THE FAILURE MODE WAS NOT CONFIRMED AS THE DEVICE WAS NOT RETURNED. 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

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE SURGICAL TECHNICIAN NOTICED THAT THE NIPPLE ON ARRAY HAD BROKEN OFF WHEN DISASSEMBLY WHILE THE SURGEON WAS CLOSING THE PATIENT. IT WAS REPORTED THAT NOTHING WAS REMAINED IN THE PATIENT AND THAT THE BREAKAGE DID NOT AFFECT THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE SURGICAL TECHNICIAN NOTICED THAT THE NIPPLE ON ARRAY HAD BROKEN OFF WHEN DISASSEMBLY WHILE THE SURGEON WAS CLOSING THE PATIENT. IT WAS REPORTED THAT NOTHING WAS REMAINED IN THE PATIENT AND THAT THE BREAKAGE DID NOT AFFECT THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11356 ARRAY RIO REGISTRATION STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. 19120214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other