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

Model Number	Z353H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: were x-rays performed to localize the needle? : no x-ray was performed because the failure was identified before it was used on the patient.Was the needle removed from the patient? : it was not used with the patient, only when placing the stitch was the needle thread disassembled, a soft suture with a different lot was requested and the same thing happened.The batches that presented the failure go in the report was the procedure completed successfully? : yes, the procedure was completed successfully.Was there any adverse patient outcome? no adverse event occurred with the patient.Procedure name? procedure: enterorraphy.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-04510.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, 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.
Event or Problem Description
It was reported that a patient underwent an enterorraphy procedure on (b)(6) 2022 and suture was used.While passing the point in the aponeurosis, the thread became disassembled from the needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 1 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; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14679910
• Report Number: 2210968-2022-04509
• Device Sequence Number: 20218466
• Product Code: NEW
• UDI-Device Identifier: 10705031060722
• UDI-Public: 10705031060722
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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
• Device Expiration Date: 07/31/2026
• Device Model Number: Z353H
• Device Catalogue Number: Z353H
• Device Lot Number: RJMQSQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown