MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC-11 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8802
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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.Attempts have been made to retrieve the device.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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The following information was requested but unavailable: it was reported that "¿over the past approx.3 weeks vascular theatres has been having trouble with ethicon prolene multipass sutures.The sutures have been breaking, the thread when used or coming out of the packet in two parts." please confirm the number of patients/events affected by this alleged deficiency? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If no, please create a new pc file for each patient/event.Please provide information requested below for each patient/event.What is the procedure name(s) and date(s)? please clarify, how many devices demonstrated the alleged deficiency ("¿the sutures have been breaking, the thread when used.")? 7/0 prolene w8704 9.3mm multipass lot ucbamm.7/0 prolene w8704 9.3mm multpass lot 100cs2.7/0 prolene w8304 9.3mm visi black lot 100e12.6/0 prolene w8802 11mm multipass lot 100d16.7/0 prolene w8304 9.3mm multipass lot tpbcma.7/0 prolene w8704 9.3mm multipass lot 101hl8.6/0 prolene w8707 13mm multipass lot tkbekr.How many devices demonstrated the alleged deficiency ("¿the sutures have been breaking, the thread.When.Coming out of the packet in two parts.")? 7/0 prolene w8704 9.3mm multipass lot ucbamm.7/0 prolene w8704 9.3mm multpass lot 100cs2.7/0 prolene w8304 9.3mm visi black lot 100e12.6/0 prolene w8802 11mm multipass lot 100d16.7/0 prolene w8304 9.3mm multipass lot tpbcma.7/0 prolene w8704 9.3mm multipass lot 101hl8.6/0 prolene w8707 13mm multipass lot tkbekr.Were there patient consequences? if yes, please specify.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).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please confirm below the number of devices from each product code and lot number available for product analysis: 7/0 prolene w8704 9.3mm multipass lot ucbamm.7/0 prolene w8704 9.3mm multpass lot 100cs2.7/0 prolene w8304 9.3mm visi black lot 100e12.6/0 prolene w8802 11mm multipass lot 100d16.7/0 prolene w8304 9.3mm multipass lot tpbcma.7/0 prolene w8704 9.3mm multipass lot 101hl8.6/0 prolene w8707 13mm multipass lot tkbekr.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in the vascular theatre on (b)(6) 2024 and suture was used.During the procedure, the sutures had been breaking, either the thread when used or coming out of the packet in two parts.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC-11 MP
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21245797
• Report Number: 2210968-2025-00988
• Device Sequence Number: 3664146
• Product Code: GAW
• UDI-Device Identifier: 10705031128361
• UDI-Public: (01)10705031128361(17)290331(10)100D16
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: W8802
• Device Lot Number: 100D16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• 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