BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PIN- 3.2 X 140MM- STERILE (2 PACK)

    MDR report key: 5022401 · Received August 21, 2015

    Report

    Report Number
    3005985723-2015-00146
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: BONE PIN BROKE WHILE SURGEON WAS DRILLING INTO PATIENT'S TIBIA. IT BROKE OFF BENEATH THE SURFACE OF THE BONE AND WAS LEFT IN THE PATIENT. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWED FAILURE IN TORSION THROUGH THE THREADS JUST ABOVE THE FLUTES. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS (SEE ATTACHMENT 1) FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (111621 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO (B)(4) ON 06/11/2015 AND ACCEPTED INTO FINAL STOCK ON 06/11/2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 111620, LOT NUMBER W39913 SHOWS FOUR ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. SEE PR ID (B)(4) FOR OTHER COMPLAINTS RELATED TO THIS LOT. AT THE TIME OF THIS INVESTIGATION, (B)(4) HAVE BEEN COMPLETED. TRACKING OF COMPLAINTS RELATED TO THE 111620 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST (B)(4). CONCLUSIONS: VISUAL INSPECTION CONFIRMED FAILURE OF THE BONE PIN. 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 DRILL GUIDE DURING PLACEMENT OF BOTH BONE PINS. DUE TO THE NON-USE OF A DRILL GUIDE AS REQUIRED PER MAKOPLASTY PARTIAL KNEE APPLICATION USER GUIDE, 206388 REVISION 01 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 TIPS OF THE BONE PINS BROKE BELOW SURFACE OF THE BONE WHILE THE SURGEON WAS DRILLING INTO THE PATIENT'S TIBIA. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S BONE. 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 TIPS OF THE BONE PINS BROKE BELOW SURFACE OF THE BONE WHILE THE SURGEON WAS DRILLING INTO THE PATIENT'S TIBIA. THE SURGEON DECIDED TO LEAVE THE TIP OF THE BONE PIN IN THE PATIENT'S BONE. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554459 BONE PIN- 3.2 X 140MM- STERILE (2 PACK) STEREOTACTIC, ACCESSORY OLO MAKO SURGICAL CORP. N/A W39913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention