BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS MINI STRAIGHT

    MDR report key: 9392002 · Received November 29, 2019

    Report

    Report Number
    3006524618-2019-00580
    Event Type
    Malfunction
    Date Received
    November 29, 2019
    Date of Event
    November 8, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    UDI-DI
    00885556694558
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3,H6: THE RETURNED INSTRUMENT USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2032177 SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW FOR LOT NUMBER 2032177 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES. VISUAL INSPECTION OF THE INSTRUMENT SHOW NO MANUFACTURING ABNORMALITIES. THE DEVICE WAS RETURNED WITH A DETACHED AND BROKEN SELF CAPTURING TRAP (TWO PIECES) 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 (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A LEFT KNEE LATERAL MENISCUS AND ACL TEAR REPAIR, THE FIRSTPASS MINI'S SELF-CATCHER BROKE OFF IN THE JOINT. THE BROKEN PIECE WAS REMOVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE AN NO SIGNIFICANT DELAY OR PATIENT INJURY WAS 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
    1185568 FIRSTPASS MINI STRAIGHT ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 72290128 2032177 00885556694558

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR