BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6335437 · Received February 16, 2017

    Report

    Report Number
    3005985723-2017-00070
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    February 9, 2017
    Report Date
    April 10, 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

    REPORTED EVENT: DURING TIBIAL BONE PIN INSERTION, THE SECOND BONE PIN, 3.2 MM X 80 MM PIN BROKE OFF. THE DISTAL END OF THE PIN WAS LEFT IN THE BONE AND THE REMAINS WERE RETURNED TO STRYKER. A 5 TO 10 MIN DELAY OCCURRED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE DEVICE CONFIRMED THAT A FRACTURE DID OCCUR. SEE ATTACHED FIGURE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ASSOCIATED LOT INDICATED (B)(4) DEVICES (43000-01 NON-STERILE BONE PIN, SINGLE) WERE MANUFACTURED SHIPPED TO (B)(6) ON MAY 23, 2016 AND ACCEPTED INTO FINAL STOCK ON MAY 23, 2016 PER ERP. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE AND CATSWEB RELATED TO P/N 143080, LOT NUMBER W44720-3 SHOWS THREE (3) ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE PR#S ARE (B)(4). CONCLUSIONS: THE FAILURE WAS CONFIRMED. 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.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING PLACEMENT OF THE TIBIAL PINS, THE SECOND PIN SNAPPED OFF LEAVING PART OF THE PIN IN THE PATIENT. THE BROKEN PIN WAS CLEANED AND COOKED.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. DURING PLACEMENT OF THE TIBIAL PINS, THE SECOND PIN SNAPPED OFF LEAVING PART OF THE PIN IN THE PATIENT. THE BROKEN PIN WAS CLEANED AND COOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120105 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTACTIC DEVICE, ROBOICS OLO MAKO SURGICAL CORP. LOT# W44720ROBOT# ROB71

    Patients

    Seq Age Sex Outcome Treatment
    1 Other