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: 7869537 · Received September 12, 2018

    Report

    Report Number
    1017294-2018-00138
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 14, 2018
    Report Date
    October 9, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS NOT CONFIRMED AS THE VISUAL EXAMINATION OF THE RETURNED OPEN PACKAGE FOUND THE CHEVRON SEAL OPEN. THE SUTURE WAS ATTACHED TO THE IMPLANT AND THE POPLOK SAFETY LEVER WAS NOT USED AND THE ANCHOR NOT DEPLOYED. THE POUCH SEALS WERE PEELED OPEN EVENLY OVER THE ENTIRE LENGTH WITHOUT DEFECTS. EVALUATION BY THE PACKAGING SPECIALIST CONFIRMED THE INITIAL EVALUATION CITING THE CONSISTENT TRANSFER OF ADHESIVE ON THE FILM SIDE. ADDITIONALLY, IF THE SEAL WAS OPEN DURING MANUFACTURING, THE DEVICE WOULD HAVE FALLEN OUT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD (DHR) HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A DHR REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF THREE (3) COMPLAINTS, REGARDING THREE (3) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 13,443 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0002. THE INSTRUCTIONS FOR USE (IFU) ADVISES THE USER: THE POPLOK KNOTLESS SUTURE ANCHOR SHOULD ONLY BE USED IF THE ORIGINAL PACKAGING AND LABELING SARE INTACT. IF THE POPLOK KNOTLESS SUTURE ANCHOR PACKAGING HAS BEEN OPENED OR ALTERED, CONTACT YOUR REGIONAL CONMED LINVATEC SALES REPRESENTATIVE OR IN THE U.S., CONTACT THE CUSTOMER SERVICE DEPARTMENT. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH GKP-2801, 2.8MM POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE . IT WAS REPORTED THAT "WHEN THE POPLOK WAS TAKEN OUT OF THE PACKAGE IT OPENED BY ITSELF, ANOTHER POPLOK WAS USED FOR THE SURGERY". ADDITIONAL INFORMATION RECEIVED CLARIFIED THE VERBIAGE "THE PACKAGE IT OPENED BY ITSELF" AND CONFIRMED THAT THE THE SEAL WAS OPENED, ONCE THE DOCTOR SAW THAT, HE PREFERRED TO USE ANOTHER ONE. IT WAS REPORTED AND CONFIRMED THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE POPLOK AND NO DELAY. THE PATIENT'S STATUS WAS STABLE AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711553 2.8MM POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE POPLOK SUTURE ANCHOR MBI CONMED CORPORATION 887920

    Patients

    Seq Age Sex Outcome Treatment
    1