MAUDE Adverse Event Report: Ethicon Inc. PROLENE; suture, nonabsorbable, synthetic, polypropylene

Catalog Number	8534H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an abdominal aortic aneurysm procedure on (b)(6) 2026 and suture was used.It was reported to the sales rep that the account contact left a message that was getting called into surgeon's room as he was doing a aaa.Apparently while he was sewing the needle came off and fell into the pt.There was no patient consequence reported.There was 35mins of surgical delay was reported.The device was returning.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 9/24/2026.H6: component code: g07002 - no device problem found.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.Additional information was requested, the following was obtained: ¿ did this issue contribute to any patient adverse event? ¿ were there any unexpected outcomes or complications resulting from the prolonged surgery time? ¿ how long, in minutes, did the surgery prolong? ¿ which tissue was being sutured when the event occurred? ¿ was additional dissection required in other organs/tissues other than the target tissue? ¿ was there any change in the patient¿s post operative care due to the prolonged procedure? ¿ please perform and document the follow up attempt for product return.Please provide tracking number issue did not contribute to a adverse event.No unexpected outcomes.Approx.20 min.Abdominal aorta.No other dissection needed.No change in post op care.Ethicon rep came to pick up box of suture.H3: investigational summary: the product was returned to ethicon for evaluation.One opened packet with thirty four unopened samples were received.Product code 8534h.Following the sampling plan, a visual inspection was conducted on thirteen (13) samples.During the initial inspection of the needle-suture piece, no needle pull-off was observed.The swage and attachment areas were noted to be as expected.The suture was removed from the overwrap and examined along the strand.Adhesive residue and curling were observed during the evaluation.The functional test was performed using instron equipment and the pull force result meet with the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no issues related to pull off - suture needle were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50883673
• Report Number: 2210968-2026-09582
• Device Sequence Number: 10704800
• Product Code: GAW
• UDI-Device Identifier: 10705031016774
• UDI-Public: 10705031016774
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial

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: 8534H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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