BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20533335 · Received October 25, 2024

    Report

    Report Number
    2210968-2024-11093
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    January 20, 2023
    Report Date
    October 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J WRIST SURG 2023;12:390¿399. HTTPS://DOI.ORG/10.1055/S-0043-1760734.

    Description of Event or Problem · 0

    TITLE: A NEW REPAIR TECHNIQUE IN PRONATOR QUADRATUS IN MANAGEMENT OF DISTAL RADIUS FRACTURE: COMPARISON WITH PRIMARY REPAIR AND UNREPAIRED TECHNIQUES. THIS STUDY AIMED TO COMPARE THE FUNCTIONAL AND CLINICAL RESULTS BETWEEN OUR NEW REPAIR TECHNIQUE IN THE GROUPS WITH AND WITHOUT PRONATOR QUADRATUS REPAIR IN DISTAL RADIUS FRACTURES TREATED WITH PLATE FIXATION USING THE VOLAR APPROACH. BETWEEN 2018 AND 2020, 77 PATIENTS (GROUP A, 21, GROUP B, 24, GROUP C, 32 PATIENTS) WHO UNDERWENT OPEN REDUCTION AND VOLAR PLATE FIXATION DUE TO DISTAL RADIUS FRACTURE WERE INCLUDED IN THE STUDY. GROUP A, B, AND C CONSISTED OF 21 (11 FEMALES, 10 MALES), 24 (10 MALES, 14 FEMALES), AND 32 (11 MALES, 21 FEMALES) PATIENTS, RESPECTIVELY. THE MEAN AGE WAS 56 YEARS IN GROUP A (RANGE: 22¿71), 61 YEARS IN GROUP B (RANGE: 24¿77), AND 59 YEARS IN GROUP C (RANGE: 20¿71). FRACTURE FIXATION WAS PERFORMED USING A COMPETITOR¿S VOLAR FIXED-ANGLE PLATE (MANUFACTURER: ACUMED). IN GROUP A, PRONATOR QUADRATUS CANNOT BE SUTURED OR TENSION MAY OCCUR, THE INTACT RADIAL FASCIA OF THE DEEP ANTERIOR FASCIA WAS PLACED UNDER THE FLEXORS TOWARD THE PRONATOR QUADRATUS AND IT WAS SUTURED WITH A 3-0 SLOW-ABSORBABLE MONOFILAMENT SUTURE (PDS II 3-0, ETHICON) TO DEEP ANTERIOR FASCIA. IN GROUP B, NO REPAIR WAS PERFORMED. IN GROUP C, PRONATOR QUADRATUS WAS SUTURED WITH TRADITIONAL METHOD. REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=1) AND ACUTE CARPAL TUNNEL SYNDROME (N=1). IN CONCLUSION, ALTHOUGH THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS IN THIS STUDY, WE THINK THAT COVERING THE PLATE MAY PREVENT LONG-TERM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890797 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention