MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z398H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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.Can you identify the lot number of the product that was used? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.Related event captured via: 2210968-2024-03990.
Event or Problem Description
It was reported that an animal underwent an animal surgery on an unknown date in (b)(6) or (b)(6) of 2023 and suture was used.During the surgery, the needle came off, but the vet was able to feel it and that needle did not fall.No patient harm was reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19059738
• Report Number: 2210968-2024-03991
• Device Sequence Number: 6602964
• Product Code: NEW
• UDI-Device Identifier: 10705031060845
• UDI-Public: 10705031060845
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• 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: Z398H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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