BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8233498 · Received January 10, 2019

    Report

    Report Number
    2210968-2019-78307
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    December 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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: CLIN ORTHOP RELAT RES. 2008; 466: 639¿645. DOI: 10.1007/S11999-007-0085-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "A MODIFIED TECHNIQUE OF ARTHROSCOPICALLY ASSISTED AC JOINT RECONSTRUCTION AND PRELIMINARY RESULTS." AUTHORS: DANIEL P. TOMLINSON MD; DAVID W. ALTCHEK MD; JEFFREY DAVILA MD; FRANK A. CORDASCO MD. CITATION: CLIN ORTHOP RELAT RES. 2008; 466: 639¿645. DOI: 10.1007/S11999-007-0085-3. SURGICAL TREATMENT OF HIGH-GRADE ACROMIOCLAVICULAR (AC) JOINT SEPARATIONS HAS BECOME ANALOGOUS TO LIGAMENT RECONSTRUCTIONS ELSEWHERE IN THE BODY WITH THE GOAL BEING RESTORATION OF THE NATIVE ANATOMY. THE AUTHORS HAVE DEVELOPED A UNIQUE ARTHROSCOPICALLY ASSISTED TECHNIQUE THAT USES A SUBACROMIAL APPROACH TO PASS SUTURE MATERIAL AND A TENDON GRAFT AROUND THE CORACOID TO RECONSTRUCT THE CORACOCLAVICULAR LIGAMENT COMPLEX. THE AUTHORS DESCRIBED THE TECHNIQUE AND PRELIMINARY RESULTS IN 10 PATIENTS (AGE RANGE: 16 TO 58 YEARS OLD) WHO HAVE UNDERGONE CORACOCLAVICULAR LIGAMENT RECONSTRUCTION FOR HIGH-GRADE AC SEPARATION. DURING THE SURGICAL PROCEDURE, IF THE CLAVICLE WAS GREATER THAN 2 CM IN ANTEROPOSTERIOR THICKNESS, TWO 5-MM HOLES COULD BE DRILLED WITH ONE SLIGHTLY POSTERIOR AND ONE SLIGHTLY ANTERIOR TO MIDLINE KEEPING A MINIMUM 10-MM BONY BRIDGE BETWEEN THE HOLES. TWO HOLES WERE MADE FOR THREE OF OUR PATIENTS. AN ETHIBOND 5-0 SUTURE (ETHICON) ON A LARGE CURVED NEEDLE WAS PLACED THROUGH THE HOLE TO ACT AS A SHUTTLE SUTURE FOR LATER GRAFT PASSAGE. AN ETHIBOND 5-0 (ETHICON) WAS PLACED THROUGH THE ANTERIOR PORTAL WITH A RIGHT-ANGLE CLAMP AND AROUND THE INFERIOR BASE OF THE CORACOID EXITING MEDIALLY. THE AUTHORS LOOPED THIS ETHIBOND 5-0 (ETHICON) SUTURE UNDER THE CORACOID WITH BOTH FREE ENDS EXITING THE SUPERIOR PORTAL TO BE USED TO SHUTTLE THE GRAFT. AFTER IRRIGATION WITH STERILE SALINE, THE DELTOTRAPEZIAL FASCIA WAS CLOSED OVER THE GRAFT WITH VICRYL 0 SUTURES (ETHICON). THE SUBCUTANEOUS TISSUE WAS CLOSED WITH VICRYL 2-0 SUTURE (ETHICON) AND THE SKIN WITH A RUNNING SUBCUTICULAR PROLENE SUTURE (ETHICON) AND STERISTRIPS. REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND "CELLULITES" (N-2) WHICH RESOLVED WITH A SHORT COURSE OF ORAL "ANTIOBIOTICS" AND MILD DISCOMFORT WITH ACTIVITIES OF DAILY LIVING (N-2). THE ARTHROSCOPICALLY ASSISTED TECHNIQUE TO TREAT AC JOINT DISLOCATIONS DESCRIBED IN THIS REPORT ALLOWS FOR EXCELLENT AND SAFE VISUALIZATION OF THE CORACOID TO RECONSTRUCT THE CORACOCLAVICULAR LIGAMENTS WITH A FREE TENDON GRAFT WHILE AT THE SAME TIME LIMITING THE POTENTIAL COMPLICATIONS ASSOCIATED WITH TRADITIONAL OPEN PROCEDURES. THE AUTHORS BELIEVED THIS TECHNIQUE OFFERS THE ARTHROSCOPIC SURGEON AN ADDITIONAL TREATMENT OPTION FOR A COMMON PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29361 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention