BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5938899 · Received September 9, 2016

    Report

    Report Number
    3005985723-2016-00286
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 29, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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: TWO MAKO ARRAY PINS 3.2 DIAMETER BY 80MM LENGTH BROKE IN A PATIENTS TIBIA AND WE'RE NOT ABLE TO BE REMOVED. WE USED TWO MAKO 4.0MM DIAMETER BY 80MM LENGTH TO COMPLETE CASE DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DIMENSION INSPECTION COMPLETED AT THE TIME OF MANUFACTURING SHOWS THE LOT WAS WITHIN SPECIFICATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (143000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON JANUARY 21, 2016 AND ACCEPTED INTO FINAL STOCK ON JANUARY 21, 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 143080, LOT NUMBER W42549-2 SHOWS FOUR COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED PI NUMBERS ARE (B)(4). AT THE TIME OF THIS INVESTIGATION, ALL THREE OF THE OTHER INVESTIGATIONS HAD BEEN COMPLETED. TRACKING OF COMPLAINTS RELATED TO THE 143080 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #789. CONCLUSIONS: AS PART OF THE INVESTIGATION INTO THIS COMPLAINT, THE STRYKER REP THAT WAS PRESENT FOR THE CASE WAS CONTACTED. IT WAS DETERMINED THAT THE SURGEON DID NOT USE THE PARALLEL DRILL GUIDE DURING THE PLACEMENT OF THE BONE PINS. THE STRYKER REP STATED THE SURGEON "DID NOT USE A DRILL GUIDE TO GUIDE PIN PLACEMENT" DUE TO THE NON-USE OF A DRILL GUIDE AS REQUIRED PER MAKOPLASTY PARTIAL KNEE APPLICATION USER GUIDE, 206388 REVISION 03 FOR PLACEMENT OF BONE PINS, THIS EVENT CONSTITUTES AN OFF-LABEL USE OF THE DEVICE. 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 PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. THE SURGEON WAS UNABLE TO REMOVE THE TIP OF THE BONE PIN IN THE PATIENT'S TIBIA. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THE TIP OF THE BONE PIN BROKE OFF IN THE PATIENT'S TIBIA. THE SURGEON WAS UNABLE TO REMOVE THE TIP OF THE BONE PIN IN THE PATIENT'S TIBIA. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592158 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W42549-2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other