BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM POPLOK SUTURE ANCHOR

    MDR report key: 8056891 · Received November 9, 2018

    Report

    Report Number
    1017294-2018-00175
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    August 16, 2018
    Report Date
    December 5, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K091549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE AND UDI INFORMATION FOR THE THREE LOTS INVOLVED IN THE SURGERY ARE: LOT 902595 EXP 02-04-2023 UDI (B)(4). LOT 723925 EXP 02-09-2021 UDI (B)(4). LOT 914466 EXP 03-22-2023 (B)(4). MANUFACTURER DATES FOR THE THREE LOTS INVOLVED IN THE SURGERY ARE: LOT 902595 ; 13FEBRUARY2018. LOT 723925 ; 16FEBRUARY2016. LOT 914466 ; 03APRIL2018. THE COMPLAINT IS CONFIRMED. ONLY THE BROKEN ACTUATOR SHAFT TIP WAS RETURNED FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED PER ASSEMBLY PRINT AND FOUND THE ACTUATOR TIP WAS BENT AND BROKEN (DETACHED) FROM THE ACTUATOR SHAFT. THE DRIVER ASSEMBLY AND ACTUATOR SHAFT WERE NOT RETURNED FOR EVALUATION. THIS IS A TECHNIQUE-DEPENDENT DEVICE AND THE MOST LIKELY CAUSE OF THIS ISSUE IS USER-RELATED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORDS FOR ALL THREE LOT NUMBERS OF THE DEVICES USED IN THE SURGERY HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND THE DHR REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. TWO-YEAR COMPLAINT HISTORY SHOWS ONE COMPLAINT FOR ONE DEVICE FOR THIS DEVICE FAMILY AND FAILURE MODE. THREE LOT NUMBERS WERE REPORTED SINCE IT IS UNKNOWN WHICH WAS LINKED TO THIS DEVICE, AND THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THESE LOTS. (B)(4). PER THE INSTRUCTIONS FOR USE THE USER IS ADVISED TO AVOID LATERAL LOADING WHEN INSERTING THE ANCHOR AND TO MAINTAIN PROPER ALIGNMENT DURING INSERTION AND DISENGAGEMENT OF THE DEVICE FROM THE DRIVER. 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

    AN ISSUE WAS REPORTED WITH THE POPLOK SUTURE ANCHOR, ITEM CKP-3500. A ROTATOR CUFF REPAIR SURGERY WAS PERFORMED ON (B)(6) 2018 WITH NO APPARENT COMPLICATIONS. THE PATIENT, A (B)(6) FEMALE, STARTED TO COMPLAIN OF PAIN A LITTLE OVER 2 MONTHS POST SURGERY. X-RAYS WERE TAKEN (B)(6) 2018 AND REVEALED AN UNKNOWN LOOSE BODY IN THE SHOULDER AREA. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2018 BY A DIFFERENT RESIDENT PHYSICIAN. AT THAT TIME, THE POPLOKS AND PREVIOUS SURGICAL SITE WERE EXAMINED, AND NO ISSUES WERE OBSERVED. NO POPLOKS WERE REMOVED HOWEVER A PIECE OF METAL WAS FOUND (AS SEEN ON THE X-RAYS) AND SURGICALLY REMOVED. THE PIECE OF METAL WAS LOCATED IN THE BONE, ON TOP OF AN EXISTING SECURED POPLOK. THE PHYSICIAN HAD TO TWIST THE PIECE OF METAL TO REMOVE IT OUT OF THE BONE. THERE WAS NO REPORTED DAMAGE TO THE EXISTING POPLOK ANCHORS AND THEY WERE LEFT IMPLANTED IN PLACE. THE LOT NUMBERS OF THE POPLOKS INVOLVED IN THE ORIGINAL SURGERY WERE PROVIDED AS LOT 902595, LOT 723925 AND LOT 914466. IT IS NOT INDICATED WHICH LOT NUMBER MAY BE INVOLVED WITH THE REPORTED ISSUE. THIS SECOND SURGERY TO REMOVE THE "LOOSE" BODY (PIECE OF METAL) WAS SUCCESSFULLY COMPLETED WITH NO REPORTED IMPACT TO THE PATIENT. AT LAST ACCOUNT, THE PATIENT HAD BEEN SEEN POST-OP, WAS HEALING WELL WITH NO COMPLICATIONS AND NO REPORTED ISSUES OF PAIN. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896936 3.5MM POPLOK SUTURE ANCHOR ANCHOR, BONE-IMPLANTED, SOFT TISSUE, NON BIODEGRADABLE MBI CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other