BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX

    MDR report key: 11178757 · Received January 15, 2021

    Report

    Report Number
    3006524618-2021-00075
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 29, 2020
    Report Date
    November 30, 2023
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LXH
    UDI-DI
    00885556724613
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THAT THE KIT WERE RETURNED IN ORIGINAL BOX WITH THE BATCH NUMBER OF THE COMPLAINT. NO DEFICIENCY OF EITHER OBTURATOR. BIO DEBRIS IS PRESENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE WAS NOT DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, EXCESSIVE TORQUE ON THE DEVICE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, TWO (2) DISPOSABLE KITS SHOULDER Q-FIX BROKE WHILE DRILLING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, THE DISPOSABLE KIT SHOULDER Q-FIX BROKE WHILE DRILLING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHOULDER SCOPE PROCEDURE, THE DISPOSABLE KIT SHOULDER Q-FIX BROKE WHILE DRILLING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. 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
    75021 DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORP. 2043461 00885556724613

    Patients

    Seq Age Sex Outcome Treatment
    1