BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR-FEM STEM-OFFSET

    MDR report key: 5352203 · Received January 7, 2016

    Report

    Report Number
    3005985723-2016-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    August 27, 2015
    Report Date
    August 27, 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

    REPORTED EVENT: AN OFFSET STEM INSERTER BROKE DURING A CASE. THIS FAILURE DID NOT IMPACT THE CASE AND THERE WAS NO PATIENT HARM. DEVICE EVALUATION AND RESULTS: THE PART WAS NOT AVAILABLE FOR INVESTIGATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 08/24/2012. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112526, LOT NUMBER 120059 SHOWS 1 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THIS COMPLAINT IS (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 112526 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST # (B)(4). CONCLUSIONS: THE ITEM IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION SO THE FAILURE MODE COULD NOT BE INVESTIGATED FULLY. THERE WAS NO PATIENT HARM AS A RESULT OF THE FAILURE. BASED ON THE INFORMATION PROVIDED AND THE LOW PATIENT RISK, NO ADDITIONAL ACTION 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

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE OFFSET STEM IMPACTOR BROKE. THIS DID NOT NEGATIVELY IMPACT THE CASE AND THE OUTCOME WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE OFFSET STEM IMPACTOR BROKE. THIS DID NOT NEGATIVELY IMPACT THE CASE AND THE OUTCOME WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9504 IMPACTOR-FEM STEM-OFFSET STEREOTACTIC DEVICE, INSTRUMENT OLO MAKO SURGICAL CORP. 120059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other