BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 6423744 · Received March 22, 2017

    Report

    Report Number
    3005985723-2017-00132
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    March 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: A BONE PIN BROKE DURING INSERTION INTO THE TIBIA. THERE WAS A 1 MINUTE DELAY BUT NO ADDITIONAL HARM. DEVICE EVALUATION AND RESULTS: NO INSPECTION WAS COMPLETED AS THE DEVICE WAS NOT RETURNED. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED ON 4/28/2016. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, LOT NUMBER W44720-2 SHOWS (B)(4) ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE : (B)(4). CONCLUSIONS: THE PART WAS NOT RETURNED SO PHYSICAL INVESTIGATION COULD NOT BE COMPLETED. NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME. 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    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.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. WHILE PLACING THE BONE PIN IN THE TIBIA, THE BONE PIN BROKE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. WHILE PLACING THE BONE PIN IN THE TIBIA, THE BONE PIN BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205727 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT #(S):W44720-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other