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

Model Number	Z398H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that an animal underwent an unknown procedure in 2021 and suture was used.During the procedure, it was reported by the vet that the needle popped of the suture one millimeter away from the swage.There were no patient consequences reported.No additional information was provided.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11399915
• Report Number: 2210968-2021-01901
• Device Sequence Number: 3302882
• Product Code: NEW
• UDI-Device Identifier: 10705031060845
• UDI-Public: 10705031060845
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 07/31/2025
• Device Model Number: Z398H
• Device Catalogue Number: Z398H
• Device Lot Number: QJMBRL
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1