MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 5-0 D/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z320H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.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.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 via: when passing the stitch and trying to tie the suture, the thread breaks.Was surgery delayed due to the reported event? no.Was the procedure completed successfully? yes.Were fragments generated? only the needle and thread.If so, were they easily removed without further intervention? yes.Patient status/result/consequences good status.Was any other medical intervention required (eg, x-rays, additional procedures, prescriptions, otc, revision): no.Is the patient part of a clinical study: no.Could you clarify if the patient suffered any signs or consequences due to the problem (suture rupture)? please provide more information.There were no consequences for the patient.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During the procedure when passing the stitch and trying to tie the suture, the thread breaks.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 30IN 5-0 D/A RB-1
• 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 ; 9083863534
• MDR Report Key: 16315418
• Report Number: 2210968-2023-00903
• Device Sequence Number: 6081710
• Product Code: NEW
• UDI-Device Identifier: 10705031060517
• UDI-Public: 10705031060517
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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 Model Number: Z320H
• Device Catalogue Number: Z320H
• Device Lot Number: RPMCBE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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