BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12492458 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08632
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    October 6, 2020
    Report Date
    August 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE AND PDS SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (MENISCAL TEARS (N=1), MEDIAL COLLATERAL LIGAMENT TEARS(N=1), ACL SUBSTANCE RUPTURE(N=1), MENISCAL INJURY) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE AND PDS SUTURE) USED FOR CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE A COMPLETE PATIENT DEMOGRAPHICS FOR PATIENTS WITH POST-OP COMPLICATIONS (MENISCAL TEARS (N=1), MEDIAL COLLATERAL LIGAMENT TEARS(N=1), ACL SUBSTANCE RUPTURE(N=1), MENISCAL INJURY)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 107 (2021) 102798; HTTPS://DOI.ORG/10.1016/J.OTSR.2020.102798. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. EVENTS WERE SUBMITTED VIA 2210968-2021-08629.

    Description of Event or Problem · 1

    TITLE: CLINICAL OUTCOMES OF ACUTE DISPLACED POSTERIOR CRUCIATE LIGAMENT TIBIAL AVULSION FRACTURE: A RETROSPECTIVE COMPARATIVE STUDY BETWEEN THE ARTHROSCOPIC SUTURE AND ENDOBUTTON FIXATION TECHNIQUES. THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY COMPARE THE CLINICAL OUTCOMES OF ACUTE DISPLACED POSTERIOR CRUCIATE LIGAMENT AVULSION FRACTURES TREATED WITH ARTHROSCOPIC SUTURE VERSUS ENDO BUTTON FIXATION. WE HYPOTHESIZED THAT THESE TWO DIFFERENT APPROACHES WOULD PRODUCE EQUALLY GOOD CLINICAL RESULTS. METHODS: A TOTAL OF 68 PATIENTS WITH IMAGING EVIDENCE OF POSTERIOR CRUCIATE LIGAMENT AVULSION FRACTURES FROM JULY 2009 TO OCTOBER 2016 WERE RETROSPECTIVELY REVIEWED. FOR SUTURE FIXATION APPROACH THE TIBIAL BONE BED AND BONE FRAGMENT WERE DEBRIDED WITH A SHAVER THROUGH THE POSTEROMEDIAL AND POSTEROLATERAL PORTALS, AND THE INFERIOR BONE BED WAS CLEARLY EXPOSED. THE PCL TIBIAL DRILL GUIDE(SMITH & NEPHEW) WAS INSERTED FROM THE AM PORTAL INTO THE POSTERIOR COMPARTMENT AT AN ANGLE OF 55, AND THE TIP OF THE GUIDE WAS POSITIONED AT THE MEDIAL AND LATERAL BORDERS OF THE TIBIAL BED. TWO2-MM TUNNELS WERE ESTABLISHED BY THE GUIDE WIRE FROM THE ANTERIOR TIBIAL CORTEX TO THE INFEROLATERAL AND INFEROMEDIAL SIDES OF THE BONE BED. A DOUBLE-STRAND NO. 5 ETHIBOND SUTURE WAS INTRODUCED THROUGH THE ANTEROLATERAL PORTAL AND WRAPPED AROUND THE PCL FROM ANTERIOR TO POSTERIOR USING AN EPIDURAL NEEDLE LOADED WITH NO. 1POLYDIOXANONE (PDS) (ETHICON). ALL THE ENDS OF THE SUTURES WERE GRASPED THROUGH THE POSTEROMEDIAL PORTAL. FOR THE ENDO BUTTON FIXATION APPROACH THE DEVICE WAS PREPARED WITH NO.5 ETHIBOND SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED MENISCAL TEARS (N=1) TREATED BY PARTIAL MENISCECTOMY IN THE ENDO BUTTON GROUP. MEDIAL COLLATERAL LIGAMENT TEARS (N=1) TREATED BY REPAIR WITH ANCHORS IN THE SUTURE GROUP, ACL SUBSTANCE RUPTURE (N=1) TREATED BY RECONSTRUCTION WITH AN AUTOGRAFTING THE SUTURE GROUP. MENISCAL INJURY WAS TREATED BY PARTIAL MENISCECTOMY. IN CONCLUSION BOTH THE ARTHROSCOPIC SUTURE AND ENDOBUTTON FIXATION METHODS FOR ACUTE DISPLACED POSTERIOR CRUCIATE LIGAMENT AVULSION FRACTURES RESULTED IN COMPARABLY GOOD CLINICAL OUTCOMES, RADIOLOGIC HEALING, AND STABLE KNEES AT MID-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389249 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention