MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z358T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a right hemicolectomy on an unknown date and suture was used.During the procedure, while sewing the colon, the suture broke.No adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? colon.What was used to complete the procedure? unknown.Patient condition? unknown.Procedure name and date? right hemicolectomy, date is unknown.Event date? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 01/05/2022.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, 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.Additional information: h6, d9, h3, h3 evaluation: an empty opened foil, a detached needle in a container, and same small sutures pieces into a petri dish of product code z358t were received for evaluation.As per visual inspection of the detached needle, the swage and attachment area were noted to be as expected, the barrel hole was noted with some remnant that appears to be suture.In addition, the suture was not received for evaluation, only can be observed into the petri dish some small sutures pieces in process of degradation caused by exposure to the environment.The product code z358t contains an absorbable suture.As the package was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.The foil was visually inspected, and no holes were observed in the cavity.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PDSII VIO 36IN 0 S/A CT
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12912410
• Report Number: 2210968-2021-12244
• Device Sequence Number: 20105138
• Product Code: NEW
• UDI-Device Identifier: 10705031060760
• UDI-Public: 10705031060760
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 07/31/2024
• Device Model Number: Z358T
• Device Catalogue Number: Z358T
• Device Lot Number: PJ5372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2019
• 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