MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	MB66G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty (tka) procedure on (b)(6) 2026 and suture was used.The needle tip broke off from an ethicon suture during a total knee arthroplasty.A needle tip broke off from an ethicon suture during a total knee arthroplasty with doctor.The surgeon was closing the fascial layer, when it was discovered that the distal tip of his suture was missing.Once that was discovered, the surgeon asked for an x-ray to be taken to see if the tip had fallen into the patient.The x-ray did not show a needle fragment present.So, the patient was closed up and there were no further issues.The delay amounted to 1-2 minutes due to needing to take an extra x-ray image.There was no reported patient harm.Because this is one of several broken needle tips on ethicon suture at this facility within the last couple of months, some of the staff tested their theory that perhaps the needle tip was being grasped and locked into the needle holder too far distally on the needle.A suture from the same lot was taken and using the same needle holders that were used in this case, a member of the staff grasped the needle on the tip similar to where the surgeon had grasped the ethibond during the case.The needle tip broke off and that fragment was kept.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts have been made to retrieve the device.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 was requested, and the following was obtained: how many devices demonstrated the alleged deficiency? 1 during the case.Did the event occur during one or multiple patient procedures? 1 procedure.What is the total number of procedures? 1.Have any of these events been previously reported to ethicon? no if so, could you please provide the corresponding reference number(s)? if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? n/a.Did the needle fall into the patient? the broken tip fragment was not found, but the surgeon determined it wasn¿t in the patient.If so, was the needle piece(s) retrieved during the same procedure? n/a.Were x-rays taken to locate the needle piece(s)? x-rays were taken but no fragment was seen on the imaging.What measures were implemented to retrieve the broken piece? x-ray.Was there any additional tissue damage resulting from the search for the needle piece? there was no search in the patient.Does a fragment of the needle remain in the patient¿s tissue? the surgeon determined it wasn¿t in the patient.If so, is there any plan in place to remove the needle piece in the future? n/a.If so, could you please provide the scheduled date for the removal? n/a.In which tissue structure was the broken needle located? n/a.What is the surgeon¿s opinion of the potential consequences for the patient? he determined it wasn¿t in the patient so no further consequences.Did the reported issue contribute to any patient adverse consequences? no.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.Can you please confirm the number of needles affected by the alleged deficiency? 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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25636438
• Report Number: 2210968-2026-06751
• Device Sequence Number: 15797557
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: (01)10705031046290(17)301231(10)10D3K8
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MB66G
• Device Lot Number: 10D3K8
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 07/19/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/18/2026; 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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
• Patient Sex: Unknown