MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8556H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/2/2026.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.Additional information was requested, the following: - how many devices demonstrated the reported alleged deficiency? (several needles came off inter-operative while using this prolene code?) - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.(customer provided me with the box of sutures from which th peyulled the defective ones.To date, i have not received the shipper kit to send one box of suture back.Will this be sent to me?) - please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(rf please send any follow up to me, many thanks).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.
Event or Problem Description
It was reported that a patient underwent an unknown cardiac surgeon on (b)(6) 2026 an suture was used.Cardiac surgeon experienced needles coming off of the suture after passing the suture through the tissue on an aortic valve repair.They saved the box from the lot # that was used.This happened with multiple sutures during the procedure.Surgical team and surgeon are very frustrated.There were no patient consequences reported.There were no significant delays.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 5-0 D/A RB-1
• 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: 24234494
• Report Number: 2210968-2026-01196
• Device Sequence Number: 18387567
• Product Code: GAW
• UDI-Device Identifier: 10705031017030
• UDI-Public: (01)10705031017030(17)300731(10)10AHEC
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 8556H
• Device Lot Number: 10AHEC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2025
• 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