BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6041961 · Received October 19, 2016

    Report

    Report Number
    3005985723-2016-00333
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: YESTERDAY DURING OUR PKA CASE WITH DR. (B)(6) AT (B)(6) MEDICAL CENTER. HE BROKE A PIN DURING PLACEMENT FOR THE ARRAYS. THIS PIN WAS PLACED IN THE PATIENTS TIBIA. AFTER HE BROKE THIS PIN IT WAS DETERMINED THAT WE NEEDED TO SWITCH TO THE 4.0 PINS INSTEAD. THE PATIENT HAD HARD BONE. WE THEN USED A STARTER DRILL BEFORE ANY OTHER PINS WERE PLACED. WE TOOK C ARM IMAGES AT THE END OF THE CASE TO DETERMINE WHERE THE PIN WAS IN THE PATIENT. THIS DELAYED COMPLETION OF THE CASE ABOUT 10 MINS. THE PINS WERE LEFT IN THE PATIENTS BONE. I HAVE ATTACHED IMAGES. 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 ((B)(4) NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(4) ON (B)(6) 2016 AND ACCEPTED INTO FINAL STOCK ON (B)(6) 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143080, LOT NUMBER W44720-3 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 143080 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #(B)(4). 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 NOT RETURNED FOR EVALUATION.

    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

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE PROCEDURE, THE SURGEON BROKE A PIN DURING PLACEMENT FOR THE ARRAYS. THE PIN WAS PLACED IN THE PATIENT'S TIBIA. THE PINS WERE LEFT IN THE PATIENT'S BONE.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE PROCEDURE, THE SURGEON BROKE A PIN DURING PLACEMENT FOR THE ARRAYS. THE PIN WAS PLACED IN THE PATIENT'S TIBIA. THE PINS WERE LEFT IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693034 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other