MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 3-0 D/A CC-30; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8849
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown vascular procedure on (b)(6) 2025 and suture was used.It was reported that sutures are snapping in vascular.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/13/2025 h6 component code: g07002 - device not returned 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.Additional information was requested, the following was obtained: please provide an answer for each patient-event: ¿(b)(4) captures the initial report for "reports of prolene sutures snapping in vascular" ¿(b)(4) captures the ambiguous multiple event report.- please confirm the number of patient-event affected by this alleged deficiency.For this complaint two patients for effected in that the snapping of the 3/0 prolene¿s happened in two cases- three sutures in total however, only two were able to be collected.- have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If not, please create a new pc file for each patient-event.This suture (3/0) has not been reported previously however, vascular theatres has reported a number of 6/0 and 7/0 prolene¿s snapping.This has been investigated and a teams follow call has been attended with results from the ethicon team.- when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? the alleged deficiency occurred on the (b)(6) 2025 for the two sutures we were able to collect.The snapping occurred when the suture was passed through tissues and pulled through and the second occurred when tying.- how many devices demonstrated the reported alleged deficiency? we had three sutures however were only able to collect two- therefore we are reporting the two sutures.- were there patient consequences? if yes, please explain.There were no patient consequences that i currently know about.- please provide the product code and lot number.Suture 1 product code ¿ w8849 3-0 prolene 31mm cc-30 90cm lot number -100g8k suture 2 product code ¿ w8849 3-0 prolene 31mm cc-30 90cm lot number ¿ 101dha - please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/25/2025 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.Additional information: h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE BLU 36IN 3-0 D/A CC-30
• 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: 22797182
• Report Number: 2210968-2025-09320
• Device Sequence Number: 8264596
• Product Code: GAW
• UDI-Device Identifier: 10705031148680
• UDI-Public: (01)10705031148680(17)290531(10)101DHA
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: W8849
• Device Lot Number: 101DHA
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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