MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A BV; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8776H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an vascular procedure on (b)(6) 2026 and suture was used.It was reported by a sales rep that, during an open-chest surgery, the suture was broken in the middle when the product was used during a vascular anastomosis.It was occurred with 2 sutures in a row despite the operation being performed using the same procedure as usual.It was not a control release needle.There was no effect on the patient.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 2/6/2026 h6 component code: g07002 - no device problem found 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.Additional information was requested, the following: * can you identify the lot number of the product used? => unk.* what is the procedure name? => a vascular anastomosis due to a cardiovascular surgery.* please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.=> the device has been received at sukagawa and will be shipped.Please check rmao.Tracking number : (b)(4).* please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).=>(b)(4).H3 investigational summary: the product was returned to ethicon for evaluation.One labeled winding former with one partially dispensed needle- suture piece and one needle-suture piece inserted in a yellow sponge was received for analysis.Product code 8776h; this code is double armed.During the initial inspection of the sample, no breakage suture was observed.Even though the extremes of the suture pieces were noted to be cut and damaged (crushed, wavy and fraying) on the suture surface likely by a surgical instrument.Besides that, wavy and body fluids were noted as well.Due to the condition of the returned sample, no functional tests could be conducted.Although no conclusion could be reached on the cause of the reported event.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed.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.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.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: PRLNE BLU 30IN 6-0 D/A BV
• 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: 24279169
• Report Number: 2210968-2026-01376
• Device Sequence Number: 12834538
• Product Code: GAW
• UDI-Device Identifier: 10705031020481
• UDI-Public: 10705031020481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/06/2026

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: 8776H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/06/2026
• 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