MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A TF; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	Z924H
Medical Device Problem Code	Material Deformation (2976)
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 breast and endocrine surgery on an unknown date and suture was used.During the procedure, , when holding the needle with the needle-holder, the needle was unusually bent, and it was almost broken (it has not broken).It was not a control release needle.Another product was used to complete the case.The product was returned for evaluation to ethicon.One paper lid, one empty winding former and one needle-suture outside its packaging were received for analysis.Product code z924h.Evaluation of the returned product revealed a broken needle, with a portion still attached to the swage area, and significant tooling marks indicative of damage from a surgical instrument.No adverse patient consequences were reported.Additional information was requested.
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 for evaluation to ethicon.One paper lid, one empty winding former and one needle-suture outside its packaging were received for analysis.Product code z924h.Evaluation of the returned product revealed a broken needle, with a portion still attached to the swage area, and significant tooling marks indicative of damage from a surgical instrument.The instructions for use contain the following caution: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PDSII VIO 27IN 4-0 S/A TF
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 21901583
• Report Number: 2210968-2025-04478
• Device Sequence Number: 21014942
• Product Code: NEW
• UDI-Device Identifier: 10705031114777
• UDI-Public: (01)10705031114777(17)280831(10)TKMLHP
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183183
• 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): 04/24/2025

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: Z924H
• Device Lot Number: TKMLHP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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