BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE

    MDR report key: 6943991 · Received October 12, 2017

    Report

    Report Number
    1017294-2017-00103
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 7, 2017
    Report Date
    November 20, 2017
    Manufacturer
    CONMED
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS RETURNED TO CONMED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE REPORTED ISSUE OF "DEFECTIVE STERILE PACKAGE", HOWEVER, UPON ADDITIONAL INSPECTION UNDER MAGNIFICATION, BLOOD WAS FOUND ON THE TIP OF THE DRIVER SHAFT. THIS INDICATED THE DEVICE HAD BEEN USED PREVIOUSLY. FURTHERMORE, THE ACTUATOR SHAFT WAS FOUND BENT AND THE ANCHOR WAS STILL ATTACHED. A REVIEW OF THE MANUFACTURING DOCUMENTS HAS VERIFIED THE DEVICES WERE PRODUCED PER CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR HISTORICAL COMPLAINT REVIEW REVEALED 1 SIMILAR EVENT HAS BEEN REPORTED FOR THIS PRODUCT. THIS SIMILAR EVENT WAS REPORTED BY THE SAME CUSTOMER. IN THAT SAME TIMEFRAME, (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE, MAKING THE RATE OF OCCURRENCE OF THIS FAILURE 0.01 PERCENT. A RISK ANALYSIS WAS PERFORMED AND FOUND TO BE ACCEPTABLE. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCT OCCURS MULTIPLE TIMES PRIOR TO USE. GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. THE CUSTOMER IS ADVISED OF THE FOLLOWING WARNING AND PRECAUTIONS SET FORTH IN THE INSTRUCTIONS FOR USE. IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    TO DATE, THE REPORTED DEVICE IS SCHEDULED TO BE SENT TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED AFTER THE DEVICE HAS BEEN EVALUATED AND A COMPLAINT INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED ON BEHALF OF A USER FACILITY THAT A GKP-2801 POPLOK ARRIVED IN A DEFECTIVE STERILE PACKAGE. PHOTOS WERE SUBMITTED THAT SHOWED THE DEVICE POKING THROUGH THE POUCH. THIS WAS FOUND BEFORE USE, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725547 2.8MM POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE POPLOK SUTURE ANCHOR MBI CONMED 709899

    Patients

    Seq Age Sex Outcome Treatment
    1