BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8 MM POPLOK SUTURE ANCHOR

    MDR report key: 19416480 · Received May 29, 2024

    Report

    Report Number
    1320894-2024-00140
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 19, 2024
    Manufacturer
    CONMED UTICA
    Product Code
    MBI
    UDI-DI
    10845854014110
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT BEING RETURNED AND THE PHOTOGRAPHIC EVIDENCE PROVIDED DOES NOT APPEAR TO VERIFY THE COMPLAINT; THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. 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. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE IMPLANT ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. SURGEON MUST CHOOSE PROPER IMPLANT SIZE BASED ON SPECIFIC PROCEDURE AND PATIENT HISTORY. 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 SELECTION AND PLACEMENT OF THE IMPLANT ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORTANT DURING IMPLANTATION OF THE POPLOK KNOTLESS SUTURE ANCHOR TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE GKP-2801, 2.8 MM POPLOK SUTURE ANCHOR, DEVICE WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) WHEN IT WAS REPORTED ¿SURGEON FOLLOWED THE IFU TO USE POPLOK 2.8MM. HE DRILLED PILOT HOLE AND INSERTED ANCHOR. WHILE TENSIONING SUTURE, THE SUTURE SLIPPED OUT FROM THE ANCHOR AND THE IMPLANT BROKE AT DISTAL END.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿RECOVERING WELL.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE GKP-2801, 2.8 MM POPLOK SUTURE ANCHOR, DEVICE WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, "SURGEON FOLLOWED THE IFU TO USE POPLOK 2.8 MM. HE DRILLED PILOT HOLE AND INSERTED ANCHOR. WHILE TENSIONING SUTURE, THE SUTURE SLIPPED OUT FROM THE ANCHOR AND THE IMPLANT BROKE AT DISTAL END." FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "RECOVERING WELL." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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
    1883873 2.8 MM POPLOK SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED UTICA 1361568 10845854014110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown