BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP FIRSTPASS STR PASSR SELF

    MDR report key: 10009304 · Received April 29, 2020

    Report

    Report Number
    3006524618-2020-00222
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 3, 2020
    Report Date
    June 8, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DISPOSABLE FIRSTPASS DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2040498 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO PREVENT DAMAGE TO THE DEVICE DURING USE. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. PER THE INTAKE TEAM; ALL EFFORTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS COMPLAINT DID NOT PROVIDE ANY RESULTS. IF ADDITIONAL SUPPORTING MEDICAL DOCUMENTS ARE RECEIVED THIS COMPLAINT WILL BE REASSESSED. VISUAL INSPECTION SHOWS NO MANUFACTURING ABNORMALITIES ON THE DEVICE. THE INSTRUMENT WAS RETURNED WITH AN CLOSED TOP BRACKET. THE NEEDLE IS BENT. THE FIRST STEP OF THE TRIGGER STAYED LOCKED IN THE CLOSED POSITION AND CANNOT BE RELEASED; THE DEVICE IS DAMAGED. THE RETURNED DEVICE IS A SINGLE USE DEVICE AND COULD NOT BE FUNCTIONAL TESTED; AN ATTEMPT WAS MADE TRYING TO TEST THE BASIC FUNCTIONS BUT DUE TO THE DAMAGES A FUNCTIONAL TEST COULD NOT BE PERFORMED. THE COMPLAINT WAS VERIFIED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE. (2) TISSUE THICKNESS (3) TIP DAMAGED OR DEBRIS BETWEEN PASSES. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SHOULDER SURGERY, THE JAW OF THE FIRSTPASS SUTURE PASSER COULD NOT BE OPENED AND STAYED LOCKED IN CLOSE POSITION AFTER TRIGGERING THE NEEDLE. THE SURGEON PULLED IT OUT FORCIBLY AND THERE WAS SLIGHT DAMAGE TO THE PATIENT'S ROTATOR CUFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE 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
    474144 DISP FIRSTPASS STR PASSR SELF PASSER HWQ ARTHROCARE CORP. 22-4038 2040498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other