BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - BONE STAPLE: ELITE

    MDR report key: 11287672 · Received February 5, 2021

    Report

    Report Number
    2939274-2021-00706
    Event Type
    Injury
    Date Received
    February 5, 2021
    Report Date
    January 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DOCK, C.C. ET AL. (2020), OUTCOMES OF NITINOL COMPRESSION STAPLES IN TARSOMETATARSAL FUSION, FOOT & ANKLE ORTHOPEDICS, VOL 5(3), PAGES 1-6 (USA). THE PURPOSE OF THIS STUDY WAS TO COLLECT AGGREGATE DATA (DEMOGRAPHIC, SURGICAL, AND PERIOPERATIVE OUTCOMES) ON PATIENTS WHO PREVIOUSLY HAD A TARSOMETATARSAL (TMT) FUSION WITH BME COMPRESSION STAPLES. BETWEEN MARCH 2014 AND APRIL 2018, A TOTAL OF 66 PATIENTS (68 FEET) WERE ANALYZED. THERE WERE 7 MEN AND 59 WOMEN WITH AN AVERAGE AGE OF 64 YEARS (RANGE, 18-83). THEY UNDERWENT TMT FUSIONS AND WERE IMPLANTED WITH BME COMPRESSION STAPLES (SYNTHES USA, LLC, MONUMENT, CO; OR BIO-MEDICAL ENTERPRISES, INC, SAN ANTONIO, TX). THE FUSIONS PERFORMED INCLUDED 32 SINGLE-TMT FUSIONS, 27 MULTIPLE-TMT FUSIONS, 4 NAVICULOCUNEIFORM AND SINGLE-TMT FUSIONS, AND 5 NAVICULOCUNEIFORM AND MULTIPLE TMT FUSIONS. THE MEAN FOLLOW-UP WAS 35.9 MONTHS (RANGE, 6-56.6). THE FOLLOWING COMPLICATIONS WERE REPORTED: 14 PATIENTS HAD DISCOMFORT OVER THE HARDWARE. HARDWARE REMOVAL PERFORMED BECAUSE OF PAIN RESULTED IN RESOLUTION OF SYMPTOMS IN ALL PATIENTS. 1 PATIENT HAD SHORTENING OSTEOTOMIES DUE TO OVERLOAD. PATIENT HAD REVISION SURGERY AND THERE WAS NO WOUND COMPLICATION. 8 CASES HAD NONUNION. 4 OF THE 8 NONUNION HAD BROKEN HARDWARE, WHEREAS IN THE OTHER 4 THE STAPLES WERE INTACT. 4 PATIENTS HAD BROKEN STAPLES; 3 WERE BROKEN 2-PRONG STAPLES OF THE THIRD TMT JOINT AND OCCURRED AT 6, 15, AND 48 MONTHS POSTOPERATIVELY. 1 PATIENT HAD BROKEN STAPLES OF BOTH THE SECOND (4-PRONG) AND THIRD (2-PRONG) TMT JOINTS AT 14 MONTHS POSTOPERATIVELY. 3 PATIENTS HAD REVISION SURGERY FOR NONUNION. BME STAPLES WERE REMOVED AND DIFFERENT FIXATION METHODS WERE EMPLOYED. 1 PATIENT HAD NONUNION AND A BROKEN STAPLE. THIS REPORT IS FOR AN UNKNOWN SYNTHES BME ELITE COMPRESSION STAPLES. THIS REPORT IS FOR (1) UNK - BONE STAPLE: ELITE. THIS IS REPORT 2 OF 6 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182964 UNK - BONE STAPLE: ELITE STAPLE, FIXATION, BONE JDR WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention