BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7847952 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75639
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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: INTERNATIONAL ORTHOPAEDICS (SICOT) (2016) 40:149¿154; DOI 10.1007/S00264-015-2776-9. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 09/25/2018 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 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? THE FACTS ARE - THERE WERE 3 CASES OF INFECTIONS AFTER THE USE OF ETHIBOND SUTURES FOR PATELLAR TENDON RE-INSERTION. THIS RATE WAS SIMILAR TO THE RATE OF INFECTION ENCOUNTERED WITH ANOTHER DEVICE (ANCHOR SUTURES) WHICH DIDN¿T CONTAIN ETHIBOND SUTURES. TRYING TO DETERMINE WHAT WAS THE ACTUAL CAUSE OF THESE INFECTIONS IS IMPOSSIBLE ¿ IT MIGHT BE RELATED TO THE PATIENTS AND THEIR COMORBIDITIES, THE SURGICAL TECHNIQUE OR THE SURGICAL DEVICE. MY DEPARTMENT HAVEN'T DISCONTINUED USE OF THE ETHIBOND SUTURES FOLLOWING THESE EVENTS, A FACT THAT SPEAKS FOR ITSELF. YET, YOU ASKED ME IF I "BELIEVE" THE SUTURE CAUSED THE INFECTION OR THERE WAS A DEFICIENCY WITH IT - I CANNOT SAY FOR CERTAIN IT HAVEN'T, ESPECIALLY IN LIGHT OF PREVIOUS REPORTS OF INFECTION OCCURRING IN PATIENTS TREATED WITH ETHIBOND SUTURES AND RECALLS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ANCHOR SUTURE FIXATION OF DISTAL POLE FRACTURES OF PATELLA: TWENTY SEVEN CASES AND COMPARISON TO PARTIAL PATELLECTOMY" AUTHOR: ASSAF KADAR1, , HAGGAI SHERMAN, MICHAEL DREXLER, ELDAD KATZ, ELY L. STEINBERG CITATION: INTERNATIONAL ORTHOPAEDICS (SICOT) (2016) 40:149¿154; DOI 10.1007/S00264-015-2776-9. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE FUNCTIONAL OUTCOMES AND COMPLICATION RATES OF ANTERIOR ANCHORING (AS) VERSUS PARTIAL PATELLECTOMY (PP) IN DISTAL POLE FRACTURES. BETWEEN AUG2006 AND OCT2011, 60 PATIENTS WITH DISTAL POLE PATELLAR FRACTURE UNDERWENT EITHER AS (N=27; N=12 MALE AND N=15 FEMALE; MEAN AGE SD OF 52 [18] YEARS) OR PP (N=33; N=14 MALE AND N=19 FEMALE; MEAN AGE SD OF 55 [20] YEARS). IN PP GROUP, PP WAS PERFORMED BY THE STANDARD TECHNIQUE USING ETHIBOND EXCEL SUTURE, WITH THE INTENT TO PRESERVE AS MUCH DISTAL POLE BONE STOCK AS POSSIBLE ACCORDING TO THE DEGREE OF DISTAL POLE COMMINUTION. POSTOPERATIVELY IN PP GROUP, COMPLICATIONS INCLUDED WOUND INFECTION (N=3) WHICH 2 PATIENTS REQUIRED DEBRIDEMENT AND 1 PATIENT REQUIRED COMPLETE PATELLECTOMY AND SERIAL DEBRIDEMENT DUE TO RECURRENT SEPTIC ARTHRITIS. AS IS NON-INFERIOR TO PP FOR FUNCTION AND PAIN AFTER DISTAL POLE PATELLAR FRACTURES AND IS SUPERIOR TO PP WITH REGARD TO OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689405 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention