MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 8X18IN 0 S/A CTB-1 CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB740D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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, 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.H6 component code: g07002 device not returned attempts have been 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.Additional information was requested, and the following was obtained: please confirm the alleged deficiency experienced with product pdpb740d.It was not possible to determine whether the needle was broken or unpolished, which resulted in an extension of the surgery time.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 operation - how long was the delay? please specify in minutes.Unk - was there any change in the patient¿s post-operative care due to the prolonged procedure? ct and x-ray scans were performed.- please perform and document the follow up attempt for product return.The device has been received and will be shipped.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2025 and suture was used.During the procedure, an issue had occurred.It was not known whether the needle was broken or whether the needle was not polished from the beginning.The operation time was extended when this event occurred because ct scans and x-rays were taken.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/21/2025.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.Additional information: d9, h3, h6.H3 investigational summary: the product received for analysis was pdpb740d.Visual inspection and metallurgical analysis were performed on the returned product.A blunt tip was observed.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of pc-001931526 revealed the needle contained a blunt tip.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PDS+ VIO 8X18IN 0 S/A CTB-1 CR
• 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: 22903515
• Report Number: 2210968-2025-09847
• Device Sequence Number: 18142874
• Product Code: NEW
• UDI-Device Identifier: 10705031218840
• UDI-Public: (01)10705031218840(17)261231(10)105S42
• Combination Product (Y/N): Y
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: PDPB740D
• Device Lot Number: 105S42
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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