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: 8307619 · Received February 5, 2019

    Report

    Report Number
    1017294-2019-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    November 7, 2018
    Report Date
    March 22, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED USED DEVICE, ITEM GKP-3301, AND FOUND ANCHORS OUTER BODY STILL ATTACHED TO THE DRIVER ASSEMBLY. ANCHOR INNER BODY WAS DETACHED AND WAS NOT RETURNED FOR THE EVALUATION. HOWEVER, UNITS SHOW SIGNS OF MISUSE DUE TO DAMAGED (BENT) DRIVER SHAFT ASSEMBLY. 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 13 COMPLAINTS, REGARDING 17 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS: 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. 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 THE ANCHOR BREAKAGE DURING IMPLANTATION IS REDUCED BY FOLLOWING THE SPECIFIED INSTRUCTIONS FOR USE LISTED BELOW. PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORTANT DURING IMPLANTATION OF THE ANCHOR TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR. BREAKAGE OF THE ANCHOR IS POSSIBLE IF: THE PILOT HOLE IS NOT DRILLED TO THE PROPER DEPTH. THE ANCHOR IS NOT PROPERLY ALIGNED WITH THE PILOT HOLE. THE ANCHOR INSERTER IS USED FOR PRYING. 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT GKP-3301, 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE, DEVICE (ANCHOR) WAS "CRUMBLING" AFTER THE SURGEON HAD ATTEMPTED TO IMPLANT THE DEVICE. THE SURGEON WAS TRYING TO REMOVE THE ANCHOR FROM THE DRIVER WHEN THIS OCCURRED. THIS TOOK PLACE ON (B)(6) 2018 DURING AN UNKNOWN TYPE OF PROCEDURE. FURTHER INFORMATION AS TO THE MEANING OF "CRUMBLING" WAS REQUESTED; HOWEVER, THE REPORTER DID NOT RESPOND TO THIS QUESTION. SINCE FURTHER INFORMATION AND EXPLANATION OF THE WORD "CRUMBLING" WAS NOT GIVEN IT IS ASSUMED THAT THIS MEANS FRAGMENTATION OF THE ANCHOR. THE DEVICE IS REPORTED TO HAVE BROKEN DURING USE, BUT NO FRAGMENTATION WAS REPORTED AS HAVING FALLEN INTO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED FOR THIS EVENT. 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
    97509 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED CORPORATION 914476

    Patients

    Seq Age Sex Outcome Treatment
    1