BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL

    MDR report key: 9826328 · Received March 12, 2020

    Report

    Report Number
    3006524618-2020-00105
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 18, 2020
    Report Date
    April 21, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HTW
    UDI-DI
    00885556657447
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THE RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED. WITHOUT THE REPORTED PRODUCT A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: (1) EXCESSIVE FORCE. (2) TISSUE THICKNESS. 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 ARTHROSCOPY, ONE 1.8 MM Q-FIX DRILL BROKE OFF INTO THE GLENOID. IT IS UNKNOWN WHETHER THE FRAGMENTS WERE REMOVED FROM THE PATIENT. IT IS ALSO UNKNOWN HOW THE SURGERY WAS COMPLETED AND IF IT WAS DELAYED. THE PATIENT OUTCOME IS UNKNOWN. 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
    291062 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL BIT, DRILL HTW ARTHROCARE CORP. 72290118 UNKNOWN 00885556657447

    Patients

    Seq Age Sex Outcome Treatment
    1