MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CP-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z466H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in mwr-2210968-2021-00578, 2210968-2021-00579, 2210968-2021-00581, 2210968-2021-00583, 2210968-2021-00584, 2210968-2021-00585, and 2210968-2021-00586.A manufacturing record evaluation was performed for the finished device batch number qcmlbc, and no non-conformances were identified.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.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.It was originally reported that ¿during multiple procedure that the vet is experiencing a lot of breakage over the past month.Another like device was used to complete the procedure".Could you please confirm how many procedures were affected by suture breakage? could you please provide the dates of these procedures? was there any quality deficiency/ non-conformance noted with the device before use/ during use or during possible re-operation? could you please confirm the device return status/follow up?(30 sterile samples) it was also reported that ¿three patients needed to be re-sutured due to wound dehiscence¿.Could you please confirm if wound dehiscence was a consequence of post-op suture breakage? could you please clarify which affected suture product was used on each patient? could you please provide the initial procedure dates, as well as the re-suturing dates?.
Event or Problem Description
It was reported that an animal underwent an unknown animal procedure on (b)(6) 2020 date and suture was used.The suture broke post-operatively.

• Brand Name: PDSII VIO 27IN 2-0 S/A CP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11214358
• Report Number: 2210968-2021-00582
• Device Sequence Number: 16712076
• Product Code: NEW
• UDI-Device Identifier: 10705031061057
• UDI-Public: 10705031061057
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 01/05/2021

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: No Information
• Device Expiration Date: 02/28/2025
• Device Model Number: Z466H
• Device Catalogue Number: Z466H
• Device Lot Number: QCMLBC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1