BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7397347 · Received April 4, 2018

    Report

    Report Number
    2210968-2018-71892
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT 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 USED IN THIS PROCEDURE? CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2016) 69, E61EE63; HTTP://DX.DOI.ORG/10.1016/J.BJPS.2015.12.016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: SALVAGE OF A COMPLEX FIRST METATARSO-PHALANGEAL JOINT INJURY AND SYNCHRONOUS RECONSTRUCTION OF MEDIAL COLLATERAL LIGAMENT AND SOFT TISSUE WITH A DISTALLY BASED MEDIAL PLANTAR ARTERY FLAP¿ AUTHORS: MUHAMMAD UMAIR JAVED AND IAN CHRISTOPHER JOSTY CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2016) 69, E61EE63; HTTP://DX.DOI.ORG/10.1016/J.BJPS.2015.12.016. THIS CORRESPONDENCE AND COMMUNICATION CASE REPORTED OF AN INJURY TO THE FIRST METATARSOPHALANGEAL JOINT (MTPJ) THAT UNDERWENT SOFT TISSUE AND MEDIAL COLLATERAL LIGAMENT RECONSTRUCTION USING A COMPOSITE PLANTAR FASCIA AND DISTALLY BASED ISLANDED MEDIAL PLANTAR ARTERY FLAP (MPAF). A (B)(6) FEMALE PATIENT PRESENTED WITH A FULL THICKNESS ABRASION TO THE FIRST MTPJ FOLLOWING A FALL FROM A SCOOTER WHILE TRAVELLING AT 30 MILES PER HOUR. AT OPERATION, THE PATIENT WAS NOTED TO HAVE A FRICTION BURN INJURY TO THE 1ST MTPJ WITH LOSS OF THE MEDIAL COLLATERAL LIGAMENT RESULTING IN AN UNSTABLE MTPJ, ABRASION OF HEAD OF METATARSAL BONE AND 2 CM LOSS OF MEDIAL DIGITAL NERVE TO THE GREAT TOE. PROXIMAL FIXATION OF THE LIGAMENT WAS ACHIEVED USING A MICRO-MITEK BONE ANCHOR SUTURE INTO THE HEAD OF THE METATARSAL. DISTAL FIXATION WAS ACHIEVED BY DIRECT SUTURE OF THE PLANTAR FASCIA USING PDS II (POLYDIOXANONE) SUTURES INTO THE COLLATERAL LIGAMENT REMNANT. AT THREE YEARS FOLLOW-UP, SHE RE-PRESENTED WITH A SMALL SWELLING AND ERYTHEMA AT THE SUPERIOR BORDER OF THE FLAP. SHE UNDERWENT EXPLORATION AND EXCISION OF A SUBCUTANEOUS MASS WHICH WAS CONFIRMED IT TO BE A SUTURE GRANULOMA ON HISTOLOGY. SHE MADE COMPLETE RECOVERY FROM HER SURGERY AND WAS DISCHARGED FROM PLASTIC SURGERY FOLLOW UP. THE PATIENT HAD NO CLINICALLY SIGNIFICANT LOSS OF FUNCTION AND THE REGAINED FULL AMBULATION POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238433 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention