BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6155260 · Received December 8, 2016

    Report

    Report Number
    3005985723-2016-00425
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    December 6, 2016
    Report Date
    February 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: BOTH TIPS OF THE 3.2X80 PINS BROKE OFF INSIDE FAR CORTEX OF BONE WHILE BEING DRILLED INTO TIBIA BY DR. (B)(6) UNDER NORMAL CIRCUMSTANCES AND WITH APPROPRIATE DRILLING TECHNIQUE. UNABLE TO REMOVE PIN TIPS FROM BONE SO SURGEON HAD TO LEAVE THE METAL IN THE BONE. DELAYED FOR: 10MINS. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 MILLSTONE ON NOVEMBER 25, 2015 AND ACCEPTED INTO FINAL STOCK ON NOVEMBER 25, 2015 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143080, LOT NUMBER W41377 SHOWS TWO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION, PR1375700 AND PR1384468. 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 USE THE DRILL GUIDE DURING PLACEMENT OF THE BONE PIN. THE BONE PIN BROKE RELATED TO ANOTHER ONE OF THE OTHER POTENTIAL CAUSES FOUND IN 2.0 AFMEA 0007 SYS R35 INCLUDING: EXCESSIVE OFF-AXIS FORCE APPLIED, HIGH PATIENT BONE DENSITY, BONE PIN REUSE FATIGUE, BONE PIN RE-DIRECTED DURING INSERTION, IMPROPER DRILL SPEED USED INCREASING TORQUE ON PIN. BASED ON THIS INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE WHICH OF THE CAUSE(S) ABOVE CONTRIBUTED TO THE FAILURE. 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 DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN BOTH TIPS OF THE 3.2 X 80 PINS BROKE OFF INSIDE THE CORTEX OF BONE WHILE BEING DRILLED INTO THE PATIENT'S TIBIA. THE PIN TIPS WERE UNABLE TO BE REMOVED FROM THE PATIENT'S BONE SO THE SURGEON OPTED TO LEAVE IT INSIDE THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN BOTH TIPS OF THE 3.2 X 80 PINS BROKE OFF INSIDE THE CORTEX OF BONE WHILE BEING DRILLED INTO THE PATIENT'S TIBIA. THE PIN TIPS WERE UNABLE TO BE REMOVED FROM THE PATIENT'S BONE SO THE SURGEON OPTED TO LEAVE IT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805162 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT NUMBER: W41377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other