BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB

    MDR report key: 22717326 · Received August 5, 2025

    Report

    Report Number
    9612501-2025-02112
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 5, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    UDI-DI
    10884521049635
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT RIGHT ACHILLES TENDON RUPTURE REPAIR SURGERY, AFTER SUCCESSFUL ANESTHESIA, A 7 CM LONGITUDINAL INCISION WAS MADE ON THE INSIDE OF THE ACHILLES TENDON RUPTURE, AND THE SKIN, SUBCUTANEOUS TISSUE, AND DEEP FASCIA WERE CUT LAYER BY LAYER UNTIL THE ACHILLES TENDON STUMP WAS EXPOSED. THE ACHILLES TENDON WAS TORN IN A HORSETAIL SHAPE ABOUT 4 CM ABOVE THE CALCANEAL TUBEROSITY, AND THE PLANTAR TENDON WAS NORMAL. THE BLOOD CLOTS WERE CLEANED, THE STUMP WAS COMBED, AND TWO HIGH-STRENGTH SUTURES (SUTURES USED IN CONJUNCTION WITH BONE ANCHORS) WERE OVERLAPPED TO SUTURE THE ACHILLES TENDON STUMP, WITH INTERRUPTED SUTURE, AND SEVERAL STITCHES WERE SUTURED THROUGH THE MIDDLE OF THE TENDON. A MEDIUM 3.5X13.2 NON-ABSORBABLE ANCHOR WITH THREAD WAS THEN INSERTED INTO THE CALCANEAL INSERTION POINT, AND THE ACHILLES TENDON WAS STRENGTHENED AND FIXED BY BRAIDING SUTURE PROXIMALLY. CHECKING THAT THE CALCANEAL TUBEROSITY WAS EQUAL TO THE OPPOSITE SIDE, THE TENSION OF THE ACHILLES TENDON WAS RESTORED, THE WOUND WAS RINSED, AND EACH LAYER WAS TIGHTLY SUTURED WITH SYNTHETIC ABSORBABLE SURGICAL SUTURE 2-0, STERILE DRESSING WAS APPLIED WITH PRESSURE BANDAGE, TOURNIQUET WAS LOOSENED, AND THE LOWER LIMB WAS FIXED WITH PLASTER POSTERIOR SUPPORT AT 30° KNEE FLEXION AND SLIGHT TALAR FLEXION. POST OPERATIVELY, ON (B)(6) 2025, IT WAS FOUND THAT THE POSTOPERATIVE INCISION WAS RED, SWOLLEN, AND CRACKED, DEEP INTO THE ACHILLES TENDON, AND THE ACHILLES TENDON WAS NECROTIC. AFTER THAT, THE NECROTIC PART WAS COMPLETELY REMOVED, THE SUTURE WAS REMOVED, AND ANOTHER SUTURE WAS USED TO REPAIR THE ACHILLES TENDON, AND IT WAS RE-SUTURED. AFTER ACTIVE DRESSING CHANGES, THE PATIENT GRADUALLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516212 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UL-878 D4M2308Y 10884521049635

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention