MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	HS6861H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information provided: for 2 consecutive threads of the same box.Prlne hs blue 36in 4-0 d/a sh-2 (hs6861h): affected side: not applicable reason why product is not available: available.Prlne hs blue 36in 4-0 d/a sh-2 (hs6861h): batch number (lot/lot): uabeak list all j&j products that were used during the case but did not contribute to the reported event.Have any injuries been reported to patients or users? no was there a significant delay? no if available, please provide your product order number (po).## (b)(4) would you like a return label at the end of this process? no.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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.
Event or Problem Description
It was reported a patient underwent an aortic valve repair on (b)(6) 2026 and suture was used.The needle has detached from the thread, the same episode had happened to a colleague of his who had previously been to him, of whom we had not become aware.No adverse patient consequences.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25658553
• Report Number: 2210968-2026-06835
• Device Sequence Number: 9424151
• Product Code: GAW
• UDI-Device Identifier: 10705031232785
• UDI-Public: (01)10705031232785(17)281231(10)UABEAK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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: HS6861H
• Device Lot Number: UABEAK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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