MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A BV175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8702
Medical Device Problem Code	Break (1069)
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 an unknown procedure in 2025 and suture was used.During the procedure, was alerted by sr that 1 ea of suture snapped during dr 's case.2nd piece was opened to continue with the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One empty labeled winding former, one needle suture combination in two sections outside the overwrap packet that pertains to product code w8702 were received for analysis.This product code is double armed.During visual inspection of the returned sample, the swage and attachment areas on the needles were observed to be as expected.The suture pieces were examined, and the ends were noted to be cut likely caused by a surgical instrument.No anomalies or issues related to breakage suture was observe during the evaluation.However, it was noted that the surface of the suture exhibited evidence of crushing.A functional test was performed in one suture piece using an instron equipment and the tensile force was above the minimum requirements.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during passage through tissue.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) on dd mmm yyyy or provided from knowledge as you were present in the case? additional h11: was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.

• Brand Name: PRLNE BLU 24IN 7-0 D/A BV175-8 MP
• 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: 22977363
• Report Number: 2210968-2025-10191
• Device Sequence Number: 9549159
• Product Code: GAW
• UDI-Device Identifier: 10705031201903
• UDI-Public: (01)10705031201903(17)47177(10)UCBBLP
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 09/05/2025

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: W8702
• Device Lot Number: UCBBLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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