BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5969062 · Received September 21, 2016

    Report

    Report Number
    3005985723-2016-00296
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 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

    REPORTED EVENT: 3.2MM X 80MM BONE PIN TIP BROKE IN PATIENTS RIGHT TIBIA PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE CONSEQUENCE TO THE PATIENT. PRODUCTS NOT AVAILABLE AS THEY WERE THROWN OUT. 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 MILLSTONE ON MARCH 29, 2016 AND ACCEPTED INTO FINAL STOCK ON MARCH 29, 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143080, LOT NUMBER W44718 SHOWS THREE COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED PI NUMBERS ARE 1276313, 1307252, AND 1348408. 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 DRILL GUIDE DURING PLACEMENT OF THE BONE PIN. 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. THE DEVICE WAS 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

    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 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 INSIDE OF THE TIBIA. 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
    619260 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. LOT NUMBER W44718-3ROBOT # R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other