MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 5IN 9-0 S/A BV130-4; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W2780
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an maxillofacial tumor flap transplantation surgery on (b)(6) 2025 and suture was used.Suture split.It was reported that the suture got split in the surgery.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/27/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/3/2026 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: d9, h3, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one detached needle and one suture piece were received for analysis.Product code w2780.Upon initial inspection it was observed that the detached needle and suture piece affixed to a petri dish with medical adhesive tape.The suture could not be removed from the tape; however, one end of the strand appeared crushed while the opposite end was noted to be cut likely by a surgical instrument.The strand also showed waves and crush damage.Per the conditions of the returned sample the functional test could not be performed.To prevent this kind of damage, care should be taken to avoid damage to the strand when handling, specifically avoiding the crushing or crimping action of surgical instruments such as needle holders and forceps.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: PRLNE BLU 5IN 9-0 S/A BV130-4
• 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: 24190393
• Report Number: 2210968-2026-00979
• Device Sequence Number: 13140039
• Product Code: GAW
• UDI-Device Identifier: 10705031126053
• UDI-Public: (01)10705031126053(17)300331(10)10841Z
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: W2780
• Device Lot Number: 10841Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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