BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN-3.2 X 80 MM-STERILE (2 PACK)

    MDR report key: 7314024 · Received March 5, 2018

    Report

    Report Number
    3005985723-2018-00113
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 20, 2018
    Report Date
    April 12, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ON 2-20-2018 DR. (B)(6) WAS PERFORMING A BILATERL PKA. DR (B)(6) STARTED ONE THE LEFT KNEE. DURING THE BONE PIN PLACEMENT ON THE TIBIA DR. (B)(6) FELT THERE WAS SOMETHING NOT RIGHT WITH THE PIN. THE PINS USED IN THIS PROCEDURE WERE THE MAKO BONE PINS 3.2MM X 8MM. DR. (B)(6) HOWEVER FELT THE PINS WERE STURDY ENOUGH ONCE PLACED IN THE TIBIA TO PROCEED WITH THE PKA PROCEDURE. 3.2MM X 140MM MAKO BONE PINS WERE PLACED IN THE FEMUR AND WE PROCEEDED ON WITH THE LEFT PKA PROCEDURE. AT THE COMPLETION OF THE PROCEDURE DR. (B)(6) REMOVED THE TIBIA ARRAY AND REMOVED THE FIRST TIBIA BONE PIN AND NOTICED THE TIP OF THE BONE PINS HAD SHEARED OFF DURING PLACEMENT. DR. (B)(6) VOICED HIS CONCERN ABOUT THESE PINS AND REMOVED THE SECOND TIBIA BONE PIN. THIS PIN ALSO HAD THE TIP SHEAR OFF DURING PLACEMENT. DR. (B)(6) WAS VERY UPSET AND VOICED HIS CONCERN OVER THESE BONE PINS. THIS IS NOT THE FIRST TIME DR. (B)(6) HAS HAD 3.2 DIAMETER PINS BREAK OFF IN THE PATIENT¿S BONE. BOTH TIPS WHICH BROKE OFF WERE LEFT IN THE PATIENT¿S TIBIA. DR. (B)(6) EXPRESSED HE WANTS TO SPEAK WITH SOMEONE FROM STRYKER ABOUT THIS PROBLEM. DR. (B)(6) HAS BEEN USING PINS FROM ANOTHER COMPANY BECAUSE OF THIS PROBLEM, HOWEVER ANIMAS SURGICAL HOSPITAL HAD RUN OUT OF THESE OTHER PINS AND DR. (B)(6) WAS FORCED TO USE THE MAKO BONE PINS. DEVICE EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: UNABLE TO PERFORM AS THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW: UNABLE TO PERFORM AS THE LOT NUMBER WAS NOT PROVIDED. 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: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE NC AND 2 CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE NC AND CAPAS ARE NC 1470754 CAPA 1480798 CAPA 301. ONE CAPA HAS BEEN COMPLETED (CATSWEB SYSTEM IS CAPA 301) WHILE THE SECOND IS STILL OPEN (TRACKWISE (B)(6)). H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    ON (B)(6) 2018 DR. (B)(6) WAS PERFORMING A BILATERL PKA. DR (B)(6) STARTED ONE THE LEFT KNEE. DURING THE BONE PIN PLACEMENT ON THE TIBIA DR. (B)(6) FELT THERE WAS SOMETHING NOT RIGHT WITH THE PIN. THE PINS USED IN THIS PROCEDURE WERE THE MAKO BONE PINS 3.2MM X 8MM. DR. (B)(6) HOWEVER FELT THE PINS WERE STURDY ENOUGH ONCE PLACED IN THE TIBIA TO PROCEED WITH THE PKA PROCEDURE. 3.2MM X 140MM MAKO BONE PINS WERE PLACED IN THE FEMUR AND WE PROCEEDED ON WITH THE LEFT PKA PROCEDURE. AT THE COMPLETION OF THE PROCEDURE DR. (B)(6) REMOVED THE TIBIA ARRAY AND REMOVED THE FIRST TIBIA BONE PIN AND NOTICED THE TIP OF THE BONE PINS HAD SHEARED OFF DURING PLACEMENT. DR. (B)(6) VOICED HIS CONCERN ABOUT THESE PINS AND REMOVED THE SECOND TIBIA BONE PIN. THIS PIN ALSO HAD THE TIP SHEAR OFF DURING PLACEMENT. DR. (B)(6) WAS VERY UPSET AND VOICED HIS CONCERN OVER THESE BONE PINS. THIS IS NOT THE FIRST TIME DR. (B)(6) HAS HAD 3.2 DIAMETER PINS BREAK OFF IN THE PATIENT¿S BONE. BOTH TIPS WHICH BROKE OFF WERE LEFT IN THE PATIENT¿S TIBIA. DR. (B)(6) EXPRESSED HE WANTS TO SPEAK WITH SOMEONE FROM STRYKER ABOUT THIS PROBLEM. DR. (B)(6) HAS BEEN USING PINS FROM ANOTHER COMPANY BECAUSE OF THIS PROBLEM, HOWEVER ANIMAS SURGICAL HOSPITAL HAD RUN OUT OF THESE OTHER PINS AND DR. (B)(6) WAS FORCED TO USE THE MAKO BONE PINS.

    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

    ON (B)(6) 2018 DR. (B)(6) WAS PERFORMING A BILATERAL PKA. DR. (B)(6) STARTED ONE THE LEFT KNEE. DURING THE BONE PIN PLACEMENT ON THE TIBIA DR. (B)(6) FELT THERE WAS SOMETHING NOT RIGHT WITH THE PIN. THE PINS USED IN THIS PROCEDURE WERE THE MAKO BONE PINS 3.2MM X 8MM. DR. (B)(6) HOWEVER FELT THE PINS WERE STURDY ENOUGH ONCE PLACED IN THE TIBIA TO PROCEED WITH THE PKA PROCEDURE. THE 3.2MM X 140MM MAKO BONE PINS WERE PLACED IN THE FEMUR AND WE PROCEEDED ON WITH THE LEFT PKA PROCEDURE. AT THE COMPLETION OF THE PROCEDURE DR. (B)(6) REMOVED THE TIBIA ARRAY AND REMOVED THE FIRST TIBIA BONE PIN AND NOTICED THE TIP OF THE BONE PINS HAD SHEARED OFF DURING PLACEMENT. DR. (B)(6) VOICED HIS CONCERN ABOUT THESE PINS AND REMOVED THE SECOND TIBIA BONE PIN. THIS PIN ALSO HAD THE TIP SHEAR OFF DURING PLACEMENT. DR. (B)(6) WAS VERY UPSET AND VOICED HIS CONCERN OVER THESE BONE PINS. THIS IS NOT THE FIRST TIME DR. (B)(6) HAS HAD 3.2 DIAMETER PINS BREAK OFF IN THE PATIENT¿S BONE. BOTH TIPS WHICH BROKE OFF WERE LEFT IN THE PATIENT¿S TIBIA. DR. (B)(6) EXPRESSED HE WANTS TO SPEAK WITH SOMEONE FROM STRYKER ABOUT THIS PROBLEM. DR. (B)(6) HAS BEEN USING PINS FROM ANOTHER COMPANY BECAUSE OF THIS PROBLEM, HOWEVER (B)(6) HOSPITAL HAD RUN OUT OF THESE OTHER PINS AND DR. (B)(6) WAS FORCED TO USE THE MAKO BONE PINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157136 BONE PIN-3.2 X 80 MM-STERILE (2 PACK) STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization