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, 2210968-2021-00581, 2210968-2021-00582, 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.Attempts have been made to retrieve the device.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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 intra-operatively.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/18/2021.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: it was reported by the account contact 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.Unopened samples of product code z466 were received for evaluation.During the visual inspection of unopened 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 or damage were observed.A functional test was performed and the pull force was above the minimum requirements.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.The device performed without any defect noted and the actual complaint sample was not returned for analysis.This report is not intended to deny that you experienced a problem with the device.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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.

• 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: 11214444
• Report Number: 2210968-2021-00579
• Device Sequence Number: 2271021
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 02/18/2021
• Patient Sequence Number: 1