BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE

    MDR report key: 9836870 · Received March 16, 2020

    Report

    Report Number
    1017294-2020-00094
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 20, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED USED DEVICE, ITEM GKP-3301, FOUND ANCHORS DETACHED FROM THE DRIVER ASSEMBLY. DRIVER SHAFT ASSEMBLY FOUND BENT (DAMAGE) AT THE TIP. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. 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 8 COMPLAINTS, REGARDING 11 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PRECAUTIONS: AVOID LATERAL LOADING WHILE INSERTING THE POPLOK KNOTLESS SUTURE ANCHOR MAINTAIN PROPER ALIGNMENT DURING INSERTION OF THE ANCHOR AND DISENGAGEMENT OF THE DRIVER. THE RISK OF POPLOK KNOTLESS SUTURE ANCHOR BREAKAGE DURING IMPLANTATION IS REDUCED BY FOLLOWING THE SPECIFIED INSTRUCTIONS FOR USE LISTED BELOW. PROPER ORIENTATION AND ALIGNMENT OF THE IMPLANT ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEEN RETURNED TO CONMED, HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE (B)(4) DEVICE WAS BEING USED DURING A SHOULDER ARTHROSCOPY AND BANKART REPAIR ON THE 27FEB20 WHEN THE ANCHOR DID NOT FULLY DEPLOY IN THE PILOT HOLE HE CREATED IN THE BONE. THUS LEAVING A DISTAL PORTION OF THE ANCHOR IN THE PILOT HOLE HE CREATED AND CRACKED PIECES OF THE ANCHOR ON THE PROXIMAL END OF THE ANCHOR SEATED CORRECTLY. HE WAS ABLE TO EXTRACT THE PROXIMAL ANCHOR PIECES WITH A PITUITARY MANUAL INSTRUMENT IN ORDER TO MINIMIZE POTENTIAL RISK TO THE PATIENTS OUTCOME. THE PROCEDURE WAS COMPLETED AND THERE WAS NO INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297454 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED CORPORATION 1045454

    Patients

    Seq Age Sex Outcome Treatment
    1