BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS MINI LEFT

    MDR report key: 9459273 · Received December 12, 2019

    Report

    Report Number
    3006524618-2019-00598
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 19, 2019
    Report Date
    March 12, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED INSTRUMENT, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. REVIEW OF COMPLAINT HISTORY OF THE REPORTED LOT NUMBER 2031696 FOR THE PAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2031696 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. VISUAL INSPECTION OF THE INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. THE DEVICE WAS RETURNED WITH A BROKEN OFF UPPER JAW IN A PLASTIC BAG; THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED INSTRUMENT; DURING FUNCTIONAL EVALUATION THE TOP JAW WAS CLOSED/OPENED AS INTENDED AND BY SQUEEZING THE LEVER AND THE NEEDLE COULD BE DEPLOYED AS INTENDED; THE COMPLAINT WAS VERIFIED BUT THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. FACTORS UNRELATED TO THE DESIGN AND MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT ARE OUTLINED IN THE PRECAUTIONARY STATES IN THE INSTRUCTION FOR USE ("IFU") PROVIDED WITH THE DEVICE ASSOCIATED WITH SET-UP AND USE OF THE DEVICE. (1) EXCESSIVE FORCE (2) DO NOT USE THIS DEVICE AS A LEVER FOR MANIPULATING HARD TISSUE OR BONE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, WHEN SETTING THE NEEDLE, THE UPPER PART OF THE BARREL WAS BROKEN OFF. ALL PARTS HAVE BEEN REMOVED FROM THE KNEE JOINT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253611 FIRSTPASS MINI LEFT ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 2031696

    Patients

    Seq Age Sex Outcome Treatment
    1