BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5672545 · Received May 23, 2016

    Report

    Report Number
    3005985723-2016-00156
    Event Type
    Malfunction
    Date Received
    May 23, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 21, 2020
    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 · 0

    WHILE REVIEWING THE COMPLAINT RECORD ASSOCIATED WITH THIS REPORT, IT WAS DISCOVERED THAT THIS EVENT WAS INCORRECTLY FILED AS A SERIOUS INJURY. WE CONFIRMED THAT THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY LIFE-THREATENING CONDITION OR PERMANENT IMPAIRMENT TO THE PATIENT AND DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. ADDITIONALLY, A REVIEW OF COMPLAINT HISTORY RECORDS FROM (B)(6) 2016 UNTIL TODAY, CONFIRMED THAT THERE HAVE BEEN NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH SIMILAR EVENTS FOR THIS DEVICE FAMILY. FINALLY, THE DEVICE¿S ASSOCIATED RISK DOCUMENTATION CONFIRMED THAT THE HIGHEST POTENTIAL SEVERITY OF HARM FOR THIS HAZARDOUS SITUATION IS A S2. THEREFORE, WE WILL NO LONGER BE FILING REPORTS FOR THIS EVENT TYPE.

    Description of Event or Problem · 0

    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 IN FEMORAL CANAL. THE BONE PIN WAS LEFT INSIDE OF THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: DURING PARTIAL KNEE SURGERY, A 3.2 X 140 BONE PIN TIP SHEARED OFF IN THE FEMUR. DRILL GUIDE WAS NOT USED. THERE WAS NO DELAY TO THE CASE, NO ADVERSE AFFECTS TO PATIENT, AND CASE WAS SUCCESSFULLY FINISHED. 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 (143000-07 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED AND SHIPPED TO MILLSTONE ON 09/28/2015 AND ACCEPTED INTO FINAL STOCK ON 09/28/2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143140, LOT NUMBER W43262 SHOWS ONE OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION, PR (B)(4). TRACKING OF COMPLAINTS RELATED TO THE 1143140 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 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. DEVICE WAS NOT RETURNED.

    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

    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 IN FEMORAL CANAL. THE BONE PIN WAS LEFT INSIDE OF THE PATIENT 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 IN FEMORAL CANAL. THE BONE PIN WAS LEFT INSIDE OF THE PATIENT AND THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328012 BONE PIN- 3.2MM X 140MM- STERILE 2 PACK STEREOTACTIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. W43262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other