MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN(45CM) USP3-0(M2) S/A SH-1 CR; SUTURES - ABSORBABLE

Catalog Number	PDP777D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a suture was used.The control release needle could not be detached.Since the problem occurred in the 1st package and the same event also occurred in the 2nd package, so the doctor did not want to use the remaining 6 packages, so retrieved as a reference item.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.Investigation summary the product was returned to ethicon for evaluation.Six unopened samples were received for analysis.The product code pdp777d is a control release and contains eight strands per packet.To evaluate the condition of the returned sample, the packets were opened, revealing eight strands in each packet.Additionally, one sample was found to have a suture detached from the needle.The swage and attachment area of forty-eight needles exhibited signs of excessive pressure.The sutures were dispensed without any issues and were examined along the strands; no defects or damage were found.A functional test was conducted on the samples using an instron machine, and it was determined that two needle-suture combinations did not meet the required pull force specifications, as they exceeded the maximum limits set by the customer.Further investigation was performed in the suture and it was found that one suture showed short insertion.In the remainder of the suture the insertion mark was noted as expected.Based on the information currently available, pull value too high, and short insertion were identified as pull out during the investigation of the samples received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, 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: PDS PLUS VIO 8X18IN(45CM) USP3-0(M2) S/A SH-1 CR
• Common Device Name: SUTURES - ABSORBABLE
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21162147
• Report Number: 2210968-2025-00564
• Device Sequence Number: 7961579
• Product Code: NEW
• UDI-Device Identifier: 10705031218796
• UDI-Public: (01)10705031218796(17)240518(10)1014SM
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 01/15/2025

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 Expiration Date: 05/18/2024
• Device Catalogue Number: PDP777D
• Device Lot Number: 1014SM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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