MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z513G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent an unknown surgery on (b)(6) 2024, and suture was used.The suture broke easily during use.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
(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.The following information was requested, but unavailable: -please provide the lot number:=>unk attempts are being 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.H6 component code: g07002 ¿ device not returned related events captured via 2210968-2024-01595.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/24/2024.The following information was received: qty to be returned of ip-01964750, ip-01968308: 2 => 0.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.

• Brand Name: PDSII VIO 18IN 4-0 S/A PS-2 PRM MP
• 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: 18747769
• Report Number: 2210968-2024-01596
• Device Sequence Number: 6328662
• Product Code: NEW
• UDI-Device Identifier: 10705031061354
• UDI-Public: 10705031061354
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: Z513G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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