MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 6-0 S/A TF; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z432H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information provided: the event had occurred two packages in a row.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.When did the suture breakage happened (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during handling prior to use on patient/ during passage through tissue / during tying provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).Please perform and document the follow up attempt for product return.The device has been shipped.H3 evaluation: product sample received for analysis.Actual sample: the product was returned to ethicon for evaluation.One used needle suture piece and one empty winding former outside the foil packet that pertains to product code.During visual inspection of the returned sample, marks from a surgical instrument were observed on the body of the needle.The suture was examined, the end of the suture was found to be cut and crushed, likely due to a surgical instrument.In addition, body fluids were present on the strand.The other section of the suture was not returned for analysis.The product code contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Representative sample: the product was returned to ethicon for evaluation.Two unopened samples were received for analysis.Product code.To evaluate the condition of the returned samples, the packages were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.A functional test was performed using instron equipment and tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformance's 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.
Event or Problem Description
It was reported a patient underwent an unknown pediatric surgery on an unknown date and suture was used.The suture was broken easily, there was no effect on the patient.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Additional information has been requested.

• Brand Name: PDSII VIO 27IN 6-0 S/A TF
• 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: 21425955
• Report Number: 2210968-2025-01853
• Device Sequence Number: 7792767
• Product Code: NEW
• UDI-Device Identifier: 10705031060937
• UDI-Public: (01)10705031060937(17)250210(10)100QAJ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: 02/10/2025
• Device Catalogue Number: Z432H
• Device Lot Number: 100QAJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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