BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS MINI STRAIGHT

    MDR report key: 9789887 · Received March 4, 2020

    Report

    Report Number
    3006524618-2020-00088
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    UDI-DI
    00885556694558
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3,H6: THE FIRSTPASS MINI STRAIGHT DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, ¿DURING A GLENOLABRAL REPAIR, THE FIRSTPASS MINI STRAIGHT WAS USED TO SUCCESSFULLY PASS 4 SUTURES. HOWEVER, AFTERWARDS THE SELF-CAPTURE MECHANISM BROKE OFF IN THE JOINT AND HAD TO BE RETRIEVED FROM WITHIN THE PATIENT." A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2042062 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES. VISUAL INSPECTION OF RETURNED DEVICE SHOWS PART OF THE DEVICE SUTURE CAPTURE IS DETACHED AND MISSING. NO OTHER MANUFACTURING ISSUE. DURING FUNCTIONAL EVALUATION, THE DEVICE SUTURE PASSED A STITCH THROUGH A FOAM MODEL AS INTENDED DESPITE THE DAMAGED SUTURE TRAP. 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) DAMAGE OR DEBRIS ON THE DEVICE 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 A GLENOLABRAL REPAIR, THE FIRSTPASS MINI STRAIGHT WAS USED TO SUCCESSFULLY PASS 4 SUTURES. HOWEVER, AFTERWARDS THE SELF-CAPTURE MECHANISM BROKE OFF IN THE JOINT AND HAD TO BE RETRIEVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS 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
    252975 FIRSTPASS MINI STRAIGHT ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 72290128 2042062 00885556694558

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR