MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 5-0 D/A RB-2; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8710H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure in 2025 and suture was used.During the procedure, it was reported by the sales rep that during an unknown number of cardiovascular procedure across multiple surgeons, the needle popped off mid anastomosis on a coronary button.Surgery was definitely disrupted and the surgeons were displeased.Cases were completed successfully.No patient harm was reported.Device was discarded.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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 information was requested, and the following was obtained via: * if possible, please confirm the number of procedures affected by this issue.(several no exact number shared).How many devices demonstrated the alleged deficiency for each involved patient/event? (2 different sutures).Can you identify the lot number of the product used? ( for product code# d3986 the following lot numbers were on the shelf in the operating room: 103xe0, 104mt8, 1056x5).Were there any unexpected outcomes or complications as a result of the disruption during the surgery? (delay in procedure).Was there any change in the patient¿s postoperative care due to the disruption in the surgery? (none).Please provide the source, name, and title of the external person providing answers for follow-up (i.E., the external person submitting answers to the sales representative).(please refer the attached email).D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/10/2025.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.Corrected information: h6 (b18 - device discarded).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Additional information: d 4.Primary udi number, h 6.Health effect - impact code.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.

• Brand Name: PRLNE BLU 30IN 5-0 D/A RB-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22179736
• Report Number: 2210968-2025-06579
• Device Sequence Number: 12946182
• Product Code: GAW
• UDI-Device Identifier: 10705031019546
• UDI-Public: 10705031019546
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 07/11/2025

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: 8710H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/15/2025; 07/11/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/11/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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