BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7848208 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75644
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: HONG KONG MED J. 2008; 14: 255-8.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : MINIMALLY INVASIVE REPAIR OF RUPTURED ACHILLES TENDON" AUTHOR: SK CHAN, STEPHEN CY CHUNG, YF HO; CITATION: HONG KONG MED J. 2008; 14: 255-8. THE ACHILLES TENDON IS THE STRONGEST TENDON IN THE BODY, AND CAN NORMALLY WITHSTAND SEVERAL TIMES A SUBJECT¿S BODY WEIGHT. NOT SURPRISINGLY, CLOSED RUPTURE OF THIS TENDON IS A COMMONLY ENCOUNTERED SPORTS INJURY. THE OBJECTIVES WAS TO STUDY THE CLINICAL OUTCOMES OF MINIMALLY INVASIVE REPAIR OF RUPTURED ACHILLES TENDON. A TOTAL OF 15 PATIENTS (14 MALE AND 1 FEMALE PATIENT; AGE RANGE: 20 TO 64 YEARS OLD) ADMITTED TO THE HOSPITAL FROM AUGUST 2002 TO APRIL 2005 WITH CLOSED ACHILLES TENDON RUPTURE, HAD IT REPAIRED BY A MINIMALLY INVASIVE METHOD. DURING THE SURGICAL PROCEDURE, BY PLACING THE INNER 2 LIMBS WITHIN THE PARATENON ENCLOSING THE RUPTURED TENDON ENDS AND THE OUTER LIMBS OUTSIDE THE SKIN, A LONG NEEDLE WITH ETHIBOND SUTURES (ETHICON) CAN BE PASSED THROUGH THE HOLES OF THE FOUR LIMBS WHILE THE ACHILLES TENDON WAS STILL SECURED BETWEEN THE INNER LIMBS. WHEN THE ACHILLON WAS WITHDRAWN, THE SUTURES THAT PASS THROUGH THE TENDON COULD BE RETRIEVED FOR APPROXIMATION OF THE RUPTURED ENDS OF THE ACHILLES TENDON. THIS METHOD REDUCES THE RISK OF SURAL NERVE ENTRAPMENT AS THE SUTURE KNOTS ARE WITHIN THE PARATENON. THE PARATENON WAS REPAIRED WITH VICRYL SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED STITCH ABSCESS (N-1) IN WHICH THE WOUND HEALED WITH CONSERVATIVE TREATMENT FOLLOWING THE USE OF ORAL ANTIBIOTICS AND WOUND DRESSING AND SKIN TETHERING TO THE UNDERLYING TISSUE (OVER THE SURGICAL WOUND; N-1) WHICH RESOLVED AFTER SUBCUTANEOUS RELEASE UNDER LOCAL ANESTHESIA. OPEN REPAIR OF THE ACHILLES TENDON IS REPORTED TO HAVE A HIGH INFECTION RATE. THE POSSIBLE REASON IS RELATED TO THE POOR BLOOD SUPPLY OF THE TENDON, ESPECIALLY AT THE WATERSHED AREA WHERE THE RUPTURE COMMONLY OCCURS. MOREOVER, THE SUTURE MATERIAL CAN ACT AS FOREIGN BODY TO ENHANCE SURVIVAL OF BACTERIA AND SUTURE KNOTS CAN FURTHER REDUCE BLOOD SUPPLY OF THE TENDON. IT WAS CONCLUDED THAT THIS MINIMALLY INVASIVE SURGICAL TECHNIQUE USING THE ACHILLON SUTURE GUIDE PRODUCES ENCOURAGING RESULTS IN THE OPERATIVE MANAGEMENT OF RUPTURED ACHILLES TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689044 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention