MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z315H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional information was requested, and the following was obtained: could you please confirm the quantity of devices that presented suture detachment from needle during this single procedure (tapp) being reported? qty of the product involved is 2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No further information is available.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: mwr-(b)(4) and mwr-(b)(4).
Event or Problem Description
It was reported that a patient underwent a tapp procedure on (b)(6) 2021 and suture was used.During the procedure, the suture was detached from the needle during continuous suturing on the peritoneum in the abdominal cavity.It was detached easily when pulling the suture.It was not a control release needle.The operation time was extended within 30 minutes.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/22/2021.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, 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.Additional information was received: we asked the sales rep but the actual device has not yet returned.Qty to be returned: 23 => 0.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11701033
• Report Number: 2210968-2021-03583
• Device Sequence Number: 3646669
• Product Code: NEW
• UDI-Device Identifier: 10705031060456
• UDI-Public: 10705031060456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021

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: 08/31/2025
• Device Model Number: Z315H
• Device Catalogue Number: Z315H
• Device Lot Number: QKMEAJ
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1