MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A C-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z127H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.H6 component code: g07002 device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm the number of patients affected by this alleged deficiency? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).What are the procedure name(s) and date(s)? please provide lot number for devices of (product code z127h - pdsii vio 30in 6-0 d/a c-1).How many devices demonstrated the alleged deficiency? were there patient consequences? if yes, please specify.Please confirm if the devices are available for product return.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2024 and suture was used.The suture broke during surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 30IN 6-0 D/A C-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21019804
• Report Number: 2210968-2024-14045
• Device Sequence Number: 9155785
• Product Code: NEW
• UDI-Device Identifier: 10705031060227
• UDI-Public: 10705031060227
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/26/2024

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 Catalogue Number: Z127H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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