MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A C-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z127H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, it was reported by the distributor per customer that product was defective.They have a box of suture (special order) that is failing on every suture they open.The needle is popping off the line.There was no patient consequences reported.The device is available for return.There were no adverse consequences 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.Additional information was requested and the following response was received: can you clarify if more than 1 needle pulled off the suture? yes.-if yes, please specify the number of sutures that the needle pulled off? 5.-when did the needle pull off? (when the package was opened, when removing from the package.During use on patient) when use on the patient.H3 investigation summary: the product was returned to ethicon for evaluation.One empty open box with twenty-six representative unopened samples were received for analysis.Product code z127h.Visual inspection of the samples, the swage, and the attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed using a instron and the pull force in three samples were below the minimum requirements, the rest of the samples meet the finished goods requirements.After the investigation of the samples, the barrel holes were examined under magnification for suture remnant, and none was observed.The suture ends were examined and there isn¿t sufficient impression at the swage end, resulting in a light swage.Based on the information currently available, the light swage issue was identified as pull out during the investigation of the sample 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 lot number, and no related non-conformances were identified.

• Brand Name: PDSII VIO 30IN 6-0 D/A C-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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21720735
• Report Number: 2210968-2025-03253
• Device Sequence Number: 17089817
• Product Code: NEW
• UDI-Device Identifier: 10705031060227
• UDI-Public: (01)10705031060227(17)290430(10)100UX4
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Z127H
• Device Lot Number: 100UX4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2024
• 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