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

Catalog Number	8411H
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
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- when did the needle detach/pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - did this event contribute to any patient adverse event? if yes, please explain.- please provide the lot number.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Attempts are being made to retrieve the device.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 procedure in 2025 and suture was used.Suture came off needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 4.Primary udi number, d 9.Device available for evaluation?, g 1.Manufacturing site name , h 3.Device evaluated by manufacturer? additional information: d 4.Lot, d 4.Expiration date., d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, g 1.Manufacturer site addr.Street line 1, g 1.Manufacturer site addr.Street line 1, g 1.Manufacturer site country code, g 1.Manufacturer site postal code, h 4.Device manufacture date, h 6.Type of investigation, h 6.Component code, h 6.Investigation findings, h 6.Investigation conclusions h6 component code: g07002 - no device problem found h3 investigation summary the product was returned to eth for evaluation.Visual inspection revelated that twenty-seven unopened samples were received for analysis.Product code 8411h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area of the needles were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issue related to pull off or anomalies were observed during evaluation.Functional testing using instron equipment showed that the pull force results were above the minimum requirements, and the device performed without any defect noted.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the devices were returned without detectable damage.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.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.

• Brand Name: PRLNE BLU 30IN 2-0 S/A CT-2
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23706715
• Report Number: 2210968-2025-13543
• Device Sequence Number: 16125111
• Product Code: GAW
• UDI-Device Identifier: 10705031015234
• UDI-Public: (01)10705031015234(17)290731(10)102JU6
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 8411H
• Device Lot Number: 102JU6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2024
• 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