MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	EH7222H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
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.H6 component code: g07002 - no findings available.H6 investigation findings: c22 - photo review.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Investigation summary: the product was returned to ethicon for evaluation.One detached needle and one suture piece outside its packaging were received for analysis.Product code eh7222h, which is a double armed product.During the visual assessment of the detached needle, the swage and attachment area were as expected.However, marks that appear to be caused by a surgical instrument were observed on the body needle.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The needle-suture piece was examined initially, revealing a correct insertion mark on one end.However, the force required to detach the needle from the suture could not be determined.On the opposite end, the swage and attachment area appeared as expected, but the edge showed marks likely caused by a surgical instrument.Additionally, the suture near the swage area was crushed, indicating possible damage during handling.As per the condition of the returned sample, the functional test could not be performed.To complement this assessment, one photograph was provided that visually documented a plastic bag with a labeled winding former with one detached needle and one needle-suture piece no conclusion could be reached as to what caused the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 cabg procedure on (b)(6) 2025 and suture was used.The problem of pulling off suture needle happened in surgery.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.

• Brand Name: PROLENE SUT 30IN(75CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22923574
• Report Number: 2210968-2025-10012
• Device Sequence Number: 18432370
• Product Code: GAW
• UDI-Device Identifier: 10705031073043
• UDI-Public: (01)10705031073043(17)280930(10)TLBCBC
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: EH7222H
• Device Lot Number: TLBCBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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