MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 5 S/A V-37; 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	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 6/13/2025.H6 component code: g07002 - no device problem found.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Two needle suture combinations outside the packaging were received for analysis.The product code mb66g is multi-strand and four strands per packet.During the visual inspection of the returned samples, the tip and body of the needles were observed intact.The sutures were inspected and no anomalies or issues related to breakage suture were observed during the evaluation.The samples were tested by resistance test to needle and met the requirements.The functional test was performed in the sutures using instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.H3.Investigational summary: the product was returned to ethicon for evaluation.One used needle suture piece outside the packaging were received for analysis.The product code mb66g is multi-strand and four strands per packet.During the visual inspection of the needle suture piece, the tip and body needle were examined and no anomalies or needle breakage were noted.The suture was examined and the end was noted to be cut probably by a surgical instrument.The needle was tested by resistance test to needle and met the requirements.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on (b)(6) 2025 and suture was used.It was reported by the rep who was in the case that during a total hip replacement procedure that the needle and the suture broke.The fragment of the needle did not break in the patient but was recovered.Another suture was used to continue with the procedure.No x-ray was needed.There were no adverse consequences reported.Product returning.There were no patient consequences reported.Additional information was requested.

• Brand Name: EB EXC GRN 4X30IN 5 S/A V-37
• 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: 22203075
• Report Number: 2210968-2025-06846
• Device Sequence Number: 7667399
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: (01)10705031046290(17)291130(10)1056ZA
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 1056ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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