BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QFIX 1.8 MINI SUTURE ANCHOR DISP KIT

    MDR report key: 9124910 · Received September 26, 2019

    Report

    Report Number
    3006524618-2019-00486
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 20, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    UDI-DI
    00885556662632
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3,H6: THE RETURNED DEVICE USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2022649 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 2022649 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES. VISUAL INSPECTION SHOWS A INCOMPLETE INSTRUMENT. THE MISSING PARTS WERE NOT RECEIVED. THE RETURNED PART OF THE INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. THE RETURNED INSTRUMENT IS A SINGLE USED DEVICE AND CAN ONLY BE LIMITED FUNCTIONAL TESTED. THE COMPLAINT WAS NOT VERIFIED AS THE REPORTED ISSUE COULD NOT BE DUPLICATED. FACTORS UNRELATED TO THE DESIGN AND MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT ARE (1) EXCESSIVE FORCE (2) NOT ADHERE THE INSTRUCTIONS FOR USE (3) IMPROPER ALIGNMENT OF THE HANDLE. 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 · 0

    THE RETURNED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AS AN MDR FOR EVALUATION. VISUAL INSPECTION SHOWS AN INCOMPLETE INSTRUMENT. THE MISSING PARTS WERE NOT RECEIVED. THE RETURNED PART OF THE INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. THE RETURNED INSTRUMENT IS A SINGLE USED DEVICE AND CAN ONLY BE LIMITED FUNCTIONAL TESTED. THE COMPLAINT WAS NOT VERIFIED AS THE REPORTED ISSUE COULD NOT BE DUPLICATED. 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 PROVIDED WITH THE DEVICE ASSOCIATED WITH SET-UP AND USE OF THE DEVICE. POTENTIAL FACTORS THAT COULD CONTRIBUTE THE REPORTED EVENT ARE: EXCESSIVE FORCE, NOT ADHERE THE INSTRUCTIONS FOR USE IMPROPER ALIGNMENT OF THE HANDLE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPIC STABILIZATION THE DEVICE BROKE WHILST DRILLING THE FIRST HOLE. ALL DEVICE FRAGMENTS WERE RETRIEVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920253 QFIX 1.8 MINI SUTURE ANCHOR DISP KIT ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 72290125 2022649 00885556662632

    Patients

    Seq Age Sex Outcome Treatment
    1