MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z333H
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 number: (b)(4).Date sent to the fda: 6/3/2022 (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.Investigation summary: as per sampling plan visual inspection were performed to thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage or suture breakage were noted.Functional test was performed, and the tensile strength result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: procedure and event date? was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? are any samples available of evaluation?.
Event or Problem Description
It was reported that a patient underwent an animal procedure on an unknown date and suture was used.During the procedure, the suture is snapping.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14598392
• Report Number: 2210968-2022-04290
• Device Sequence Number: 5492131
• Product Code: NEW
• UDI-Device Identifier: 10705031060548
• UDI-Public: 10705031060548
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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 Model Number: Z333H
• Device Catalogue Number: Z333H
• Device Lot Number: RPMCAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/03/2022
• Date Device Manufactured: 12/06/2021
• 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