MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 4 X 30"(75CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #:(b)(4).H6 component code: g07002 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a breast reduction procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported by the sales reps who was in the case that, during the procedure the surgeon was tying down the anastomosis and the suture snap in half.Product is available for return.No adverse patient consequences were reported.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.Corrected information: d4 udi.Additional information: h3, h6.H3 investigation summary: the product was returned to ethicon for evaluation.One combination of a needle-suture piece and one suture piece were received for analysis.Product code epm8703.During the visual inspection of the needle, the swage and attachment area were noted to be as expected.The received suture pieces were inspected, and no breakage suture was observed.Even though the extremes were noted to be cut and a damaged (crushed) near the swage area probably caused by a surgical instrument.Furthermore, elongation suture and body fluids were also observed on the strand.As per the condition of the returned sample, the functional test could not be performed.In addition, marks that appear to be caused by a surgical instrument were observed on the body needle.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PROLENE SUTURE 4 X 30"(75CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22749164
• Report Number: 2210968-2025-09203
• Device Sequence Number: 21011451
• Product Code: GAW
• UDI-Device Identifier: 10705031203587
• UDI-Public: (01)10705031203587(17)270831(10)SKBDHH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: EPM8703
• Device Lot Number: SKBDHH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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