BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7776598 · Received August 13, 2018

    Report

    Report Number
    2210968-2018-75093
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ETHICON PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: TECHNIQUES IN SHOULDER & ELBOW SURGERY _ VOLUME 18: 65-71, NUMBER 2, JUNE 2017 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : QUADRUPLE REPAIR TECHNIQUE FOR ACROMIOCLAVICULAR DISLOCATION" AUTHOR: FABIO DAL MOLIN, MSC,* MARTA G. FEDER, MSC,W AND GONZALO R.G. GAIBOR, MDZ CITATION: TECHNIQUES IN SHOULDER AND ELBOW SURGERY _ VOLUME 18: 65-71, NUMBER 2, JUNE 2017. THE OBJECTIVE OF THE PRESENT STUDY WAS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF A SERIES OF PATIENTS WITH ACUTE ACROMIOCLAVICULAR (AC) JOINT DISLOCATION (ROCKWOOD TYPE IV AND V) WHO WERE SURGICALLY TREATED WITH REDUCTION OF THE DISLOCATED AC JOINT ASSOCIATED WITH QUADRUPLE FIXATION: CORACOCLAVICULAR (CC) CERCLAGE, TRANSFER OF THE PROXIMAL INSERTION SITE OF THE CORACOACROMIAL LIGAMENT TO THE CLAVICLE WITH THE AID OF ARTHROSCOPY, AC JOINT FIXATION WITH A MALLEOLAR SCREW, AND DELTOID-TRAPEZIUS IMBRICATION. FROM APRIL 2005 TO APRIL 2011, 20 PATIENTS (1 PATIENT, M, (B)(6) WHO HAD MOTORCYCLE ACCIDENT; 1 PATIENT, M, (B)(6) WHO HAD MOTORCYCLE ACCIDENT; 1 PATIENT, M, (B)(6) WHO HAD MARTIAL ARTS FALL; 1 PATIENT, M, (B)(6) WHO HAD FALL FROM A BICYCLE; 1 PATIENT, M, (B)(6), THAT HAD A RUN OVER; 1 PATIENT, M, (B)(6) WHO HAD FALL TO THE GROUND; 1 PATIENT, M, (B)(6) WHO HAD A FALL FROM A SKATEBOARD; 1 PATIENT, M, (B)(6) WHO HAD FALLEN WHILE PLAYING SOCCER; 1 PATIENT, M, (B)(6) WHO HAD A MOTORCYCLE ACCIDENT; 1 PATIENT, M, (B)(6) WHO HAD FALLEN DOWN THE STAIRS; 1 PATIENT, M, (B)(6) WHO HAD MOTORCYCLE ACCIDENT; 1 PATIENT, M, (B)(6) WHO FELL WHILE PLAYING SOCCER; 1 PATIENT, M, (B)(6) WHO HAD FALL TO THE GROUND; 1 PATIENT, M, (B)(6) WHO FELL WHILE PLAYING SOCCER; 1 PATIENT, M, (B)(6) WHO FELL FROM A HORSE; 1 PATIENT, M, (B)(6) WHO HAD CAR ACCIDENT; 1 PATIENT, M (B)(6), WHO HAD MOTORCYCLE ACCIDENT; 1 PATIENT, M, (B)(6) WHO FELL WHILE PLAYING SOCCER; 1 PATIENT, F, (B)(6) WHO FELL TO THE GROUND; AND 1 PATIENT, M, (B)(6) WHO HAD MOTORCYCLE ACCIDENT) MET THE ELIGIBILITY CRITERIA AND WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE CORACOACROMIAL LIGAMENT IS PEELED OFF THE UNDERSURFACE OF THE ACROMION WITH A RADIOFREQUENCY PROBE AND RELEASED FROM THE ACROMION INSERTION SITE LATERALLY AND MEDIALLY UP TO THE CORACOID PROCESS. THEN, THE CORACOACROMIAL LIGAMENT IS TAGGED WITH A 0 PROLENE SUTURE (ETHICON, (B)(4)) AND ATTACHED TO A GRASPING FORCEPS LEFT IN THE SUBACROMIAL SPACE. THE GRASPING FORCEPS ATTACHED TO THE CORACOACROMIAL LIGAMENT IS PUSHED UNTIL IT CAN BE VISUALIZED IN THE MEDIAL INCISION, AND THE LIGAMENT IS REPAIRED WITH KRACKOW STITCHES USING A NO. 2 ETHIBOND SUTURE (ETHICON). TWO NO. 5 ETHIBOND SUTURES (ETHICON) ARE PASSED RIGHT BELOW THE CORACOID PROCESS THROUGH 2 HOLES, ONE MADE IN THE LATERAL AND ANTERIOR ASPECT AND THE OTHER IN THE MEDIAL AND POSTERIOR ASPECT OF THE CLAVICULAR SHAFT, MIMICKING THE INSERTION OF THE TRAPEZOID AND CONOID LIGAMENTS, RESPECTIVELY. THE ARTHROSCOPE IS REINSERTED INTO THE SUBACROMIAL SPACE AND, WITH VISUALIZATION THROUGH THE POSTERIOR PORTAL, A GRASPING FORCEPS WITH A NO. 5 ETHIBOND SUTURE (ETHICON) ATTACHED TO ITS END IS PASSED THROUGH THE LATERAL PORTAL ALONG THE UNDERSURFACE OF THE CORACOID PROCESS UNTIL ITS MIDDLE PORTION. THE DELTOTRAPEZIAL FASCIA IS CLOSED WITH AN INTERRUPTED NONABSORBABLE 0 MERSILENE (ETHICON) SUTURE, IMBRICATING THE DELTOID AND TRAPEZIUS MUSCLES. REGARDING COMPLICATIONS, 2 PATIENTS (10%) SHOWED SIGNS OF OSTEOARTHRITIS OF THE AC JOINT AND NONE HAD CLAVICLE OSTEOLYSIS. FOUR PATIENTS (20%) DEVELOPED SEROMA AFTER SURGERY, 2 WERE TREATED WITH CIPROFLOXACIN FOR 21 DAYS AND 2 RECEIVED NO ANTIBIOTICS. ALL 4 PATIENTS HAD NEGATIVE BACTERIAL CULTURES. IN CONCLUSION, REDUCTION OF THE DISLOCATED AC JOINT ASSOCIATED WITH TEMPORARY FIXATION WITH A 4.5 MM MALLEOLAR SCREW, TRANSFER OF THE PROXIMAL INSERTION SITE OF THE CORACOACROMIAL LIGAMENT TO THE CLAVICLE, AND DELTOID-TRAPEZIUS IMBRICATION SHOWED A HIGH PERCENTAGE OF SATISFACTORY RESULTS, ACCORDING TO THE UCLA CRITERIA. IF SURGERY IS INDICATED, THIS QUADRUPLE REPAIR TECHNIQUE IS RECOMMENDED FOR THE TREATMENT OF ACUTE TYPE IV AND V AC JOINT DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618230 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention