MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8581H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The following information was requested, but unavailable: when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if different, please explain.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that two needle suture pieces were received for analysis.The product code 8581h is double armed.During visual inspection of the returned samples, the swage and attachment area were observed to be as expected.The suture pieces were examined, and the ends were noted to be cut likely caused by a surgical instrument.No anomalies or issues related to breakage suture was observe during the evaluation.A functional test was performed in one needle suture piece using instron equipment and the tensile force was above the minimum requirements.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.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 that a patient underwent a heart bypass procedure on (b)(6) 2025 and suture was used.The suture was broken when the surgeon attempted to sew the tissue.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 4-0 D/A BB
• 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 PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23843796
• Report Number: 2210968-2025-14292
• Device Sequence Number: 9445098
• Product Code: GAW
• UDI-Device Identifier: 10705031017368
• UDI-Public: (01)10705031017368(17)290930(10)1044SZ
• 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
• Report Date (Section B): 12/18/2025

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: 8581H
• Device Lot Number: 1044SZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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