MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 24"(60CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	EPM8205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.H6 component code: g07002 device not returned.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: according to sales feedback on 10/apr/2025 via phone, impacted product epm8205's quantity to be returned changed from 1 to 0 ,customer requests investigation photos.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.Additional information was previously received that no device is being returned.Please clarify what is meant by "the customer requests investigation photos".What photos is the customer requesting?.
Event or Problem Description
Breakage suture.It was reported that the suture broke when sewing in an unknown surgery.Changed another one to continue the surgery, the same problem happened again.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: ¿ please clarify what is meant by "the customer requests investigation photos".What photos is the customer requesting? --received information as following from sales rep via phone today.Clerical error, actually the customer does not request investigation photos.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: PROLENE SUTURE 2 X 24"(60CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21909033
• Report Number: 2210968-2025-04517
• Device Sequence Number: 4221321
• Product Code: GAW
• UDI-Device Identifier: 10705031207455
• UDI-Public: (01)10705031207455(17)290731(10)102XS1
• 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,Followup
• Report Date (Section B): 05/21/2025

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: EPM8205
• Device Lot Number: 102XS1
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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