BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS MINI STRAIGHT

    MDR report key: 9302444 · Received November 9, 2019

    Report

    Report Number
    3006524618-2019-00542
    Event Type
    Malfunction
    Date Received
    November 9, 2019
    Date of Event
    October 16, 2019
    Report Date
    June 18, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    UDI-DI
    00885556694558
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED AS THE PRODUCT WAS NOT RETURNED. WITHOUT THE REPORTED PRODUCT A FULLY VISUAL AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER¿S COMPLAINT CANNOT BE CONFIRMED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITHOUT EVALUATION OF THE DEVICE; HOWEVER, FACTORS UNRELATED TO THE MANUFACTURE OR DESIGN OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) EXCESSIVE FORCE. THE INSTRUCTION FOR USE WAS REVIEWED AND FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE FIRSTPASS MINI STRAIGHT DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. FROM THE INFORMATION PROVIDED, "DURING A PROCEDURE, THE DEVICE WAS TWISTED AND IT BROKE." A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2030016 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. VISUAL EVALUATION SHOWS THE DRILL GUIDE HANDLE IS DETACHED FROM SHAFT. THE DRILL IS STUCK INSIDE THE GUIDE, WRAPPED WITH SURGICAL TAPE, AND CANNOT BE REMOVED. FUNCTIONAL EVALUATION IS NOT POSSIBLE DUE TO THE DRILL AND DRILL GUIDE DAMAGE. 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. 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 A PROCEDURE, THE DEVICE WAS TWISTED AND IT BROKE. BROKEN PIECES WERE REMOVED FROM THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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
    1096685 FIRSTPASS MINI STRAIGHT ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 72290128 2030016 00885556694558

    Patients

    Seq Age Sex Outcome Treatment
    1