BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP FIRSTPASS STR PASSR SELF

    MDR report key: 15243146 · Received August 17, 2022

    Report

    Report Number
    3006524618-2022-00355
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 28, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    UDI-DI
    00885556724545
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. 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. A CLINICAL REVIEW STATES PER CASE DETAILS, THE BROKEN JAW WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURIES OR ADVERSE CONSEQUENCES WERE REPORTED. SINCE NO PATIENT INJURIES ARE BEING REPORTED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE ORIGINAL PACKAGING CONFIRMING PART NUMBER (B)(4) AND LOT NUMBER 2090272. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE (2) TISSUE THICKNESS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY A FIRSTPASS BOTTOM JAW BROKE OFF AND IT WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541664 DISP FIRSTPASS STR PASSR SELF PASSER HWQ ARTHROCARE CORP. 2090272 00885556724545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention