BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECKPOINT, 3.5MM HEX X 15MM, STERILE

    MDR report key: 6131849 · Received November 29, 2016

    Report

    Report Number
    3005985723-2016-00403
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 23, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    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: A PELVIC CHECKPOINT WAS LEFT IN THE PATIENT AFTER THE SURGEON IMPACTED IT TO DEEPLY. THE SURGEON WAS UNABLE TO REMOVE THE CHECKPOINT. THE SURGEON DECIDED TO PROCEED WITH THE CASE MANUALLY PER THEIR PREFERENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BUT ISSUES CAUSED A 30 MINUTE DELAY INTRA-OP. DEVICE EVALUATION AND RESULTS: THE CHECKPOINT WAS LEFT IN THE PATIENT. NO EVALUATION COULD BE COMPLETED. DEVICE HISTORY REVIEW: UNABLE TO PERFORM AS THE L/N WAS NOT REPORTED AND PRODUCT LABELING WAS DISCARDED AND NOT RETRIEVABLE. THE PRODUCT UNDER INVESTIGATION IS A DISPOSABLE. COMPLAINT HISTORY REVIEW: A CATALOG LEVEL SEARCH OF COMPLAINTS RELATED TO THE FAILURE IDENTIFIED IN THIS INVESTIGATION YIELDED 3 ADDITIONAL COMPLAINTS. THESE ARE PR'S (B)(4). CONCLUSIONS: THE CAUSE OF THE HARM WAS DUE TO USER ERROR OF OVERIMPACTION OF THE PELVIC CHECKPOINT. THE SURGICAL TECHNIQUE, 210555 VERSION 00, INCLUDES SPECIFIC INSTRUCTION AND WARNING ABOUT THE PLACEMENT AND ORIENTATION OF THE PELVIC CHECKPOINT. ADDITIONALLY, THERE HAS NOT BEEN AN IDENTIFIED TREND OF THIS TYPE OF FAILURE. AS A RESULT, NO ADDITIONAL INVESTIGATION IS REQUIRED. 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 TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTICS ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE REAMING PHASE, THERE WAS NO POWER TO THE MICS ATTACHMENT. THE CUTTER WAS RESET IN THE POWER, HOWEVER IT STILL DID NOT RESOLVE THE ISSUE. THE SURGEON SUCCESSFULLY COMPLETED THE CASE MANUALLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTICS ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE REAMING PHASE, THERE WAS NO POWER TO THE MICS ATTACHMENT. THE CUTTER WAS RESET IN THE POWER, HOWEVER IT STILL DID NOT RESOLVE THE ISSUE. THE SURGEON SUCCESSFULLY COMPLETED THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782394 CHECKPOINT, 3.5MM HEX X 15MM, STERILE STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization