BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP ASSEMBLY- 3-PIN

    MDR report key: 5314816 · Received December 21, 2015

    Report

    Report Number
    3005985723-2015-00310
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 23, 2015
    Report Date
    November 23, 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: THE REPORTED DEVICE WAS CONFIRMED TO BE A CLAMP ASSEMBLY- 3-PIN, P/N 112390, LOT NUMBER UNKNOWN, RMA 226111. DEVICE EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NC 1028569 HAS BEEN INITIATED TO ADDRESS MISSING PRODUCT. DEVICE HISTORY REVIEW: A DHR REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. COMPLAINT HISTORY REVIEW: A PROPER COMPLAINT INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. TRACKING OF COMPLAINTS RELATED TO THE 112390 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #813. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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. PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    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 SCREW DETACHED FROM THE CLAMP ASSEMBLY. 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 MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE SCREW DETACHED FROM THE CLAMP ASSEMBLY. 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
    840565 CLAMP ASSEMBLY- 3-PIN STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other