BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

    MDR report key: 8055772 · Received November 9, 2018

    Report

    Report Number
    2210968-2018-77071
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    October 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (STEEL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (STEEL SUTURE) INVOLVED? CITATION: J HAND MICROSURG (JULY¿DECEMBER 2013) 5 (2): 68¿73; DOI 10.1007/S12593-013-0100-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "COMPARISON OF TRANSVERSE INTRAOSSEOUS LOOP TECHNIQUE AND PULL OUT SUTURE FOR REINSERTION OF THE FLEXOR DIGITORUM PROFUNDUS TENDON. A RETROSPECTIVE STUDY," AUTHOR(S): ISTVÁN ZOLTÁN RIGÓ & MAGNE RØKKUM. CITATION: J HAND MICROSURG (JULY¿DECEMBER 2013) 5 (2): 68¿73; DOI 10.1007/S12593-013-0100-8. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE RESULTS OF TWO METHODS FOR REINSERTION OF FLEXOR DIGITORUM PROFUNDUS TENDONS. BETWEEN "JAN205" AND MAY2010, 35 FINGERS OF 29 PATIENTS WERE ASSIGNED TO PULL-OUT SUTURE (POS) GROUP, AND 13 FINGERS OF 11 PATIENTS WERE ASSIGNED IN TRANSVERSE INTRAOSSEOUS LOOP GROUP WERE INCLUDED IN THIS COMPARATIVE STUDY. IN POS GROUP, A 4-0 STAINLESS STEEL SUTURE (ETHICON) WAS PLACED IN A MODIFIED KESSLER PATTERN IN THE PROXIMAL TENDON STUMP AND THREADED THROUGH THE LOOP OF THE PULL-OUT WIRE PROXIMALLY. THE PULL-OUT WIRE WAS PASSED PROXIMALLY ALONG THE TENDON SHEATH PENETRATING THE SKIN NEAR THE PIP JOINT CREASE. POSTOPERATIVELY, COMPLICATIONS IN POS GROUP INCLUDED SUPERFICIAL INFECTIONS (N=4) CURED WITH ORAL ANTIBIOTICS; RUPTURE OF REPAIR (N=1); SIGNIFICANT PIP JOINT CONTRACTURE (N=1); SIGNIFICANT DIP JOINT CONTRACTURE (N=1); ADHESION (N=1) TREATED WITH TENO-ARTHROLYSIS; GRANULOMAS (N=2) WHICH WAS RESECTED; NAIL DEFORMITY (N=1); AND POSTOPERATIVE CARPAL TUNNEL SYNDROME (N=1) TREATED WITH CARPAL TUNNEL RELEASE. THE HIGH INCIDENCE OF INFLAMMATORY CHANGES, GRANULOMAS AND INFECTIONS IN POS GROUP MAY BE RELATED TO SOFT TISSUE IRRITATION. THE CARPAL TUNNEL SYNDROME IN OUR MATERIAL IS NOT A DIRECT COMPLICATION TO THE TENDON SURGERY, BUT IT IS A KNOWN COMPLICATION TO ANY HAND OPERATIONS WITH EXCESSIVE OEDEMA. AS IT OCCURRED EARLY POSTOPERATIVELY WITHOUT ANY PATHOLOGY IN THE CONTRALATERAL HAND, IT MIGHT BE A CONSEQUENCE OF SOFT TISSUE IRRITATION AND SWELLING; THAT IS WHY WE CONSIDERED IT AS A COMPLICATION. IN OUR OPINION THE HIGHER COMPLICATION RATE WITH POS IS DUE TO THE DISSIMILARITY IN TECHNIQUE AND NOT TO THE REHABILITATION PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896013 SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention