BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SMALL STRAIGHT HANDLE

    MDR report key: 4110820 · Received September 23, 2014

    Report

    Report Number
    1723170-2014-01011
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 18, 2014
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. PRODUCT IS CLASS I FOR US REGULATIONS AND DOES NOT REQUIRE A 510(K) DESIGNATION. RMA ISSUED. REPLACEMENT SMALL STRAIGHT RATCHETING HANDLE SHIPPED TO SITE (B)(4) 2014. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION: LOT NUMBER AND MANUFACTURE DATE PROVIDED. FURTHER ENGINEERING ANALYSIS FOUND THAT THERE IS AN ASYMMETRICAL FRACTURE PATTERN THROUGH THE THREADS OF THE REMAINING PORTION OF THE IMPACT CAP AND TEARS IN THE SILICONE ALONG THE OUTER DIAMETER OF WHERE THE IMPACT CAP ATTACHES TO THE HANDLE. THE SILVER CAP IS MISSING THEREFORE ANY DAMAGE TO THE CAP CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015. STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURE DATE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL PATIENT WEIGHT WAS (B)(6) WHICH WOULD NOT FIT IN THE FIELD DUE TO CHARACTER LIMITATIONS. CORRECTION: THE DATE OF EVENT WAS REPORTED TO BE (B)(6) 2014. THE PROCEDURE WAS A LUMBAR FUSION L5-S1. CORRECTION: THE LOT NUMBER OF THE RETURNED DEVICE WAS 43777 WHICH CORRESPONDS TO A MANUFACTURE DATE OF MARCH 04, 2013. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF PHYSICAL DAMAGE. AS REPORTED, THE CAP HAS BEEN BROKEN FROM THE HANDLE. THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY CAUSE OF THE REPORT WAS REPEATED HAMMERING OF THE DEVICE DURING USE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE METAL PIECE ON THE TOP OF A SMALL STRAIGHT RATCHETING HANDLE DETACHED WHILE BEING HAMMERED ON. NO FURTHER DETAILS REGARDING THE DAMAGE WERE PROVIDED. AN ALTERNATE INSTRUMENT WAS USED TO CONTINUE AND THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589969 RATCHETING SMALL STRAIGHT HANDLE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. NI 9212102229

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR