BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

    MDR report key: 10050159 · Received May 12, 2020

    Report

    Report Number
    3006524618-2020-00253
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 20, 2020
    Report Date
    June 29, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE DISPOSABLE FIRSTPASS SUTURE PASSER, SELF DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS NOT ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2040498 FOUND NO NON-CONFORMANCE'S OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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. VISUAL INSPECTION SHOWS NO MANUFACTURING ABNORMALITIES ON THE DEVICE. THE INSTRUMENT WAS RETURNED WITH A CLOSED TOP BRACKET. THE NEEDLE IS BENT. THE FIRST STEP OF THE TRIGGER STAYED LOCKED IN THE CLOSED POSITION AND CANNOT BE RELEASED. AN ATTEMPT WAS MADE TO TEST THE BASIC FUNCTIONS OF THE INSTRUMENT BUT DUE TO THE DAMAGE IT IS NOT POSSIBLE. THE COMPLAINT WAS VERIFIED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, 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 (3) DEBRIS OR DAMAGE ON THE TIP BETWEEN PASSES. THERE WERE NO INDICATIONS 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 AN ARTHROSCOPY THE FIRST-PASS SUTURE WAS NOT PASSING THROUGH THE ROTATOR CUFF. THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED USING AN SMITH & NEPHEW ACCUPASS DEVICE. A DELAY OF 10 MINUTES WAS REPORTED. NO PATIENT INJURY OR 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
    509575 DISPOSABLE FIRSTPASS SUTURE PASSER, SELF PASSER HWQ ARTHROCARE CORP. 22-4038 2040498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R