MAUDE Adverse Event Report: Ethicon Inc. ETHIBOND EXCEL; suture, nonabsorbable, synthetic, polyethylene

Catalog Number	D6165
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used.Post-op, the patient came back with a wound dehiscence within two weeks post-op.The patient underwent surgical intervention to close the incision that dehisced.The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously.The surgeon believes this is why the knots fell apart post-op and caused a dehiscence.Additional information was requested.
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information provided: i put that 5 eaches were affected, but the exact number is unknown.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.(b)(4) represents case 1.(b)(4) represents case 2.(b)(4) represents case 3.(b)(4) represents case 4.(b)(4) represents case 5.For each patient, please provide the following information: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? what tissue dehisced? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the suture break? if so, where was the break noted (termination, middle, end)? did the suture pull out of the tissue? did the knots untie? were there any precipitating patient stress factors that led to the sutures untying, breakage or pulling out of the tissue? are photos available? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? lot number? would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the events?.

• Brand Name: ETHIBOND EXCEL
• Common Device Name: suture, nonabsorbable, synthetic, polyethylene
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50497893
• Report Number: 2210968-2026-08752
• Device Sequence Number: 9431572
• Product Code: GAT
• UDI-Device Identifier: 10705031026117
• UDI-Public: 10705031026117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D6165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown