MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 5-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z303H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(6).H6 component code: g07002 - device problem found.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 was obtained via: was there any change in the patient¿s post-operative care due to the prolonged procedure? no any.* were there any unexpected outcomes or complications as a result of the prolonged surgery time? na * what tissue was being sutured when the event occurred? vascular anatomosys * was additional dissection required in other organs/tissues other than the target tissue? yes in order to perform another anastomosys after the first one made with pds.* what is the lot number? not retrievable.Product already shipped.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.Visual inspection was conducted on the returned device.The returned sample revealed that it was received one unopened sample that pertains to product code z303h.Upon initial inspection, of the sample, no external damages were observed on the packet.Visual inspection of the unopened sample, no defects were found on the packet.The sample was opened, and the swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined along the strand and no defects, damage, or suture breakage were noted.A functional test was performed using an instron equipment and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.
Event or Problem Description
It was reported that a patient underwent an anastomosis procedure in 2023 and suture was used.During the procedure, the surgeon was performing an anastomosis with a suture, he was closing the knot the suture got broken.Than he choused another suture of the same type, but it got broken as well.At the end he had to perform the anatomoses with another kind of suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 5-0 S/A RB-1
• 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 ; 9083863534
• MDR Report Key: 17600028
• Report Number: 2210968-2023-06077
• Device Sequence Number: 20410024
• Product Code: NEW
• UDI-Device Identifier: 10705031060357
• UDI-Public: 10705031060357
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/22/2023

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: 02/28/2025
• Device Catalogue Number: Z303H
• Device Lot Number: QCMPBU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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