MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	PDP464H
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
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the thread breaks when knotting.Would healing impaired.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/21/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: it was reported that "wound healing impaired".How was the wound healing impaired treated? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.According to original ed: thread breaks oftentimes when knotting.What exactly does "oftentimes" mean? several times during the same procedure? did it happen during other procedures? was it reported earlier to ethicon? 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.

• Brand Name: PDS+ VIO 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20034214
• Report Number: 2210968-2024-08772
• Device Sequence Number: 6507893
• Product Code: NEW
• UDI-Device Identifier: 10705031462496
• UDI-Public: (01)10705031462496(11)240111(17)251231(10)UAMECH
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K061037
• 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

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: 12/31/2025
• Device Catalogue Number: PDP464H
• Device Lot Number: UAMECH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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