MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1667G
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One empty open overwrap and one labeled winding former with two needle-sutures were received for analysis.Product code 1667g; this product code is single armed.An overall review of the sample shows that one extra needle/suture of the same product code was received.During the visual inspection of the winding former, there is visible damage outside on one slot, indicating that two needles were improperly placed in the tray.This resulted in a wrong number of strands in the package.Based on the information currently available, the extra needle suture issue was identified as wrong number of strands during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with one unopened overwrap packet was received for analysis.Product code 1667g.To evaluate the condition of the returned sample, the packet was opened.The paper cover was removed from the tray, and it was found to contain one single armed strand, which aligns with the requirements for product code 1667g.Additionally, the needle-suture combination corresponds to this product code.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 missing component / incorrect quantity 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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, the product was supposed to be a single-armed suture, but it was a double-armed suture.It was not a control release needle.When we send the sample to you, we will let you know its return date and tracking number.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHLN BLK 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 23500679
• Report Number: 2210968-2025-12620
• Device Sequence Number: 8858365
• Product Code: GAR
• UDI-Device Identifier: 10705031001817
• UDI-Public: (01)10705031001817(17)300430(10)108GZK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 11/07/2025

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: 1667G
• Device Lot Number: 108GZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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