BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5690618 · Received June 1, 2016

    Report

    Report Number
    3005985723-2016-00171
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: AT THE BEGINNING OF A MAKO MEDIAL PKA DR. (B)(6) WENT TO PLACE A 3.2MM X 80MM BONE PIN IN THE TIBIA. HE PLACED THE FIRST ONE WITH NO PROBLEM BUT WHEN HE WENT TO PLACE THE 2ND PIN THE TIP OF THE PIN BROKE OFF IN THE PATIENTS TIBIA. THE SIZE IS APPROXIMATELY 1-2MM. ONCE THE MEDIAL PKA WAS COMPLETE DR. (B)(6) HAD TO MAKE A SMALL INCISION IN THE PATIENTS TIBIA AND USE A UNIVERSAL SCREW KIT TO RETRIEVE THE BROKEN PIECE OF BONE PIN. [THE SURGICAL DELAY WAS] LESS THAN 15 MINUTES. 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 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 THREE COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED PI NUMBERS ARE (B)(4). AT THE TIME OF THIS INVESTIGATION, NEITHER OF THE OTHER TWO 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 "NO DRILL GUIDE WAS USED FOR THE PLACEMENT OF THE PINS." 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. THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S TIBIA, THE BONE PIN BROKE OFF INSIDE OF THE TIBIA. THE SURGEON HAD TO MAKE A SMALL INCISION TO RETRIEVE THE BROKEN PIECE AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE WHILE THE SURGEON WAS DRILLING A BONE PIN INTO THE PATIENT'S TIBIA, THE BONE PIN BROKE OFF INSIDE OF THE TIBIA. THE SURGEON HAD TO MAKE A SMALL INCISION TO RETRIEVE THE BROKEN PIECE AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347110 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W42549-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other