BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7805249 · Received August 22, 2018

    Report

    Report Number
    2210968-2018-75322
    Event Type
    Injury
    Date Received
    August 22, 2018
    Report Date
    August 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. 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 (ETHIBOND SUTURE) 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 (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: EUR J ORTHOP SURG TRAUMATOL (2015) 25:827¿832, DOI 10.1007/S00590-015-1617-2, PUBLISHED ONLINE: 11 MARCH 2015 CITATION: REV ASSOC MED BRAS 2015; 61(4):341-346 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ANATOMIC LOCKING PLATE AND CORACOCLAVICULAR STABILIZATION WITH SUTURE ENDO-BUTTON TECHNIQUE IS SUPERIOR IN THE TREATMENT OF NEER TYPE II DISTAL CLAVICLE FRACTURES" AUTHOR: MUSTAFA SEYHAN, BARIS KOCAOGLU, GORKEM KIYAK, AREL GERELI, METIN TURKMEN CITATION: EUR J ORTHOP SURG TRAUMATOL (2015) 25:827¿832, DOI 10.1007/S00590-015-1617-2, PUBLISHED ONLINE: 11 MARCH 2015. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE CLINICAL RESULTS OF THREE DIFFERENT FIXATION TECHNIQUES FOR THE TREATMENT OF NEER TYPE IIB FRACTURES. THERE WERE 36 PATIENTS WITH NEER TYPE IIB FRACTURES TREATED WERE INCLUDED IN THE STUDY AND EVALUATED. PATIENTS WERE DIVIDED INTO THREE GROUPS ACCORDING TO SURGICAL CHOICE THAT WAS PERFORMED: TENSION BAND AND CORACOCLAVICULAR SUTURE STABILIZATION WITH K-WIRES WAS DEFINED AS GROUP 1 (10 PATIENTS; 6 MALES AND 4 FEMALES, AGE RANGE: 26 TO 44), ANATOMIC LOCKING PLATE AND CORACOCLAVICULAR STABILIZATION WITH SCREW WAS DEFINED AS GROUP 2 (12 PATIENTS; 9 MALES AND 3 FEMALES, AGE RANGE: 34 TO 41), AND ANATOMIC LOCKING PLATE AND CORACOCLAVICULAR STABILIZATION WITH SUTURE ENDO-BUTTON (LPES) WAS DEFINED AS GROUP 3 (14 PATIENTS; 10 MALES AND 4 FEMALES, AGE RANGE: 20 TO 55). MEAN FOLLOW-UP PERIOD WAS 32.4 MONTHS. DURING THE PROCEDURE IN THE TENSION BAND AND CORACOCLAVICULAR SUTURE STABILIZATION WITH K-WIRES (TBKWS) TECHNIQUE, NO: 5 ETHIBOND SUTURE PASSED UNDER CORACOID PROCESS AND OVER MEDIAL CLAVICLE WHILE HOLDING THE MEDIAL FRAGMENT REDUCED. A GROOVE UNDER CORACOID PROCESS WAS MADE TO AVOID SLIPPAGE, AND A SECURE KNOT WAS MADE UNDER TENSION AFTER FRACTURE REDUCTION. TWO 2 MM K-WIRES INSERTED FROM ACROMION THROUGH FRACTURE SITE, AND CERCLAGE WIRE TENSION BAND TECHNIQUE WAS APPLIED TO SECURE THE FIXATION FOR OSTEOSYNTHESIS. IN TBKWS GROUP, FIVE PATIENTS SUFFERED FROM DISCOMFORT CAUSED BY SKIN EROSION DUE TO PIN MIGRATION WITH RESIDUAL DISPLACEMENT NOTED IN THREE OF THEM. IN THIS GROUP, ONE NONUNION AND TWO-DELAYED UNION WAS REPORTED. FOR THAT REASON, SECOND SURGERY WAS PERFORMED TO REMOVE DISPLACED PINS. THIRD SURGERY WAS PERFORMED FOR DELAYED AND NONUNION CASES. BOTH UNION TIME AND COMPLICATION RATES SHOWED THAT K-WIRE FIXATION WITH ETHIBOND SUTURE AUGMENTATION WAS NOT ENOUGH TO RESIST THREE-DIMENSIONAL LOADS ON CORACOCLAVICULAR AREA AND DISTAL CLAVICLE. IN CONCLUSION, ANATOMIC LOCKING PLATE AND CORACOCLAVICULAR STABILIZATION WITH SUTURE ENDO-BUTTON TECHNIQUE PROVIDED MORE STABLE AND BIOMECHANICALLY SUPERIOR FIXATION AMONG OTHER TECHNIQUES WITH LOW COMPLICATION RATES IN THE TREATMENT OF NEER TYPE IIB FRACTURES. IT ALSO REDUCES THE RATE OF REOPERATION BY PROVIDING STABLE OSTEOSYNTHESIS WITHOUT COMPROMISING PHYSIOLOGY OF SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648411 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING PLATES, SCREWS, K WIRES