SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

Additional Manufacturer Narrative

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 TRAUMA ACUTE CARE SURG. 2024 OCT 15. HTTPS://DOI.ORG/10.1097/TA.0000000000004440. EPUB AHEAD OF PRINT. PMID: 39733286.

Description of Event or Problem

TITLE: SURGICAL MANAGEMENT OF COSTAL MARGIN RUPTURE ASSOCIATED WITH INTERCOSTAL HERNIA: EVOLUTION OF TECHNIQUES. THE AIM OF THIS STUDY WAS TO CHARACTERIZED THESE INJURIES AND DESCRIBE THE EVOLUTION OF OUR SURGICAL MANAGEMENT TECHNIQUES. BETWEEN JANUARY 2006 AND JULY 2023, A TOTAL OF 25 PATIENTS UNDERWENT SURGERY WERE INCLUDED IN THE STUDY. DIVIDED INTO TWO GROUPS: THE CMR-IH CONSISTS OF 14 MALE, 1 FEMALE WITH MEAN AGE OF 61.4 [ RANGE OF 11.8] YEARS AND THE TDIH GROUPS, RESPECTIVELY CONSISTS OF 9 MALE, 1 FEMALE AGE WITH MEAN AGE OF 58 [ RANGE OF 7.0] YEARS. THE NO. 2 AND NO 5 ETHIBOND SUTURES (ETHICON, SOMERVILLE, NJ) WERE USED IN THESE PATIENTS.(GORETEX; GOREMEDICAL, FLAGSTAFF, AZ) FELT PLEDGETS, WITH INTERCOSTAL SUTURES PLACED BOTH CEPHALAD AND CAUDAL TO THE IH DEFECT: THE ¿MARK [MK] 1¿ REPAIR (SCHEMATIC DIAGRAMS OF SURGICAL REPAIR. TECHNIQUES; BIOLOGIC MESH PATCHES, USING PERMACOL (MEDTRONIC, MINNEAPOLIS, MN) OR THE SIMILAR CELLIS (MECCELLIS, LA ROCHELLE, FRANCE) (MEDTRONIC, MINNEAPOLIS, MN) OR THE SIMILAR CELLIS (MECCELLIS, LA ROCHELLE, FRANCE). IN THE ¿MK 2¿ DLMR, BIOLOGIC MESH WAS SECURED USING AN INTERCOSTAL NERVE-SPARING TECHNIQUE, WITH PAIRS OF SUTURE HOLES DRILLED 1-CM APART INTO THE TWO RIBS CAUDAL TO THE IH DEFECT. LONG EXTERNAL CORTICAL TITANIUM BUTTRESS PLATES WERE PLACED (EITHER RIBFIXBLU [ZIMMER BIOMET] OR MATRIXRIB [DEPUY SYNTHES]) THE NUMBER OF SCREWS PLACED THROUGH THESE PLATES DEPENDED ON WHETHER ASSOCIATED SURGICAL STABILIZATION OF NONUNITED RIB FRACTURES (SSNURF) WAS REQUIRED. WITH FOLLOW-UP MEDIAN (43; RANGE, 2¿190 MONTHS). REPORTED COMPLICATIONS: NO. 2 AND NO 5 ETHIBOND SUTURES (ETHICON, SOMERVILLE, NJ), STAINLESS STEEL WIRE. PNEUMONIA (N=1), TREATMENT: NOT REPORTED, NEUROPATHIC PAIN (N=1), TREATMENT: NOT REPORTED, RUQ HERNIA AT 38 MO (N=1), TREATMENT: NOT REPORTED, RECURRENT INTERCOSTAL HERNIATION(IH), TREATMENT: NOT REPORTED. IN CONCLUSIONS, LIKE OTHER CASE SERIES, WE ENCOUNTERED SURGICAL FAILURES. FIRST, THERE WERE PATIENTS WHERE THE PRECISE NATURE OF THE INJURY WAS NOT RECOGNIZED, INDICATING THE NEED TO RAISE AWARENESS ABOUT COSTAL MARGIN INJURIES AND THE SHEFFIELD CLASSIFICATION. SECOND, IT IS BELIEVED THAT THE FAILURES FOLLOWING SURGICAL REPAIR OCCURRED AS A RESULT OF THE SIGNIFICANT FORCES NORMALLY BORNE BY THE COSTAL MARGIN IN THIS GENERALLY OBESE POPULATION OF PATIENTS. THIS STUDY DESCRIBES THE EVOLUTION OF SURGICAL TECHNIQUES TOWARD THE OPTIMAL LOAD BEARING OF THESE FORCES BY MEANS OF THE MK 3 DLMR.