BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP FIRSTPASS STR PASSR SELF

    MDR report key: 9311776 · Received November 12, 2019

    Report

    Report Number
    3006524618-2019-00553
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 18, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3,H6: THE RETURNED DEVICE USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2024289 SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW FOR LOT NUMBER 2024289 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES. VISUAL INSPECTION SHOWS A DEVICE WHICH WAS RETURNED DEPLOYED. THE INSTRUMENT WAS RETURNED WITH AN OPENED BRACKET. THERE WERE NO MANUFACTURING ABNORMALITIES FOUND ON THE DEVICE. THE JAW WAS BROKEN AND RECEIVED SEPARATELY. FUNCTIONAL EVALUATION REVEALED THAT THE TWO STEP TRIGGER PERFORMED AS INTENDED. THE BRACKET COULD BE OPENED /CLOSED AS SPECIFIED. THE NEEDLE COULD BE EXTENDED WITHOUT ANY ISSUES. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE COULD BE DETERMINED AS AN MECHANICAL COMPONENT FAILURE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOREIGN ZIP CODE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER GRASPING THE ROTATOR CUFF TISSUE FOR THE THIRD TIME, THE SUTURE COULD NOT BE CAPTURED, THE FIRST PASS GOT BROKEN INSIDE THE PATIENT. PIECES WERE REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH BACK-UP DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY 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
    1105712 DISP FIRSTPASS STR PASSR SELF PASSER HWQ ARTHROCARE CORP. 22-4038 2024289

    Patients

    Seq Age Sex Outcome Treatment
    1