MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP311H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One empty labeled winding former and one suture piece were returned for analysis.Product code pdp311h.During the visual inspection of the sample, no breakage suture was observed.Even though the extreme was noted to be cut probably caused by a surgical instrument.The product code pdp311h contains an absorbable suture.As the sample was received open, the time of exposure to the environment cannot be determined.As per the condition of the returned sample, the functional test could not be performed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with thirty representative unopened samples received for analysis.Product code pdp311h.Following the sampling plan, a visual inspection was conducted on thirteen samples.The packets were open, and the swage and attachment area were noted to be as expected.These ones were tested to verify the dispensability of the sutures, and it was not possible in all samples due to the suture being found hard to release from the tray by applying excessive force.Due to this inconsistency, the remaining twenty-three samples were tested to verify the dispensability of the sutures, and it was not possible in all samples due to the suture being found hard to release from the tray by applying excessive force.Based on the information currently available, the indispensable suture was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an orthopedic trauma surgery in july 2025 and suture was used.During the procedure, it was reported that the suture was broken when the surgeon attempted to sew muscles.Total 3 products occurred suture breakage issue.Changed another one to complete the surgery.There is no report on patient's injury.There will return 3 actual products and 33 representative samples for analysis.No additional information could be provided.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/20/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Corrected information: h6 investigational codes.

• Brand Name: PDS+ VIO 27IN 3-0 S/A SH-1
• Common Device Name: SUTURE, SURGICAL, 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22849220
• Report Number: 2210968-2025-09535
• Device Sequence Number: 8403377
• Product Code: NEW
• UDI-Device Identifier: 10705031048003
• UDI-Public: (01)10705031048003(17)45869(10)TJMEPJ
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 07/31/2025
• Device Catalogue Number: PDP311H
• Device Lot Number: TJMEPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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