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

Model Number	Z467H
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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 a bulldog underwent a canine c-section procedure in 2020 and the suture was used.After the surgery, the suture got loose.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/27/2021.Additional information: d4, d9, h4, h6.A manufacturing record evaluation was performed for the finished device lot number qdmaxp, and no non-conformances related to the reported complaint condition were identified.H6 component code: g07002 ¿ conforming device.Additional h3 investigation summary: it was received for evaluation an unopened sample of product code z467h, lot qdmaxp.During the visual inspection of unopened sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.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.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The device performed without any defect noted and the actual complaint sample was not returned for analysis.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.

• Brand Name: PDSII VIO 27IN 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: 11108047
• Report Number: 2210968-2021-10434
• Device Sequence Number: 17156353
• Product Code: NEW
• UDI-Device Identifier: 10705031061071
• UDI-Public: 10705031061071
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 03/31/2025
• Device Model Number: Z467H
• Device Catalogue Number: Z467H
• Device Lot Number: QDMAXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Patient Age: 4 YR