MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP339H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total laparoscopic hysterectomy procedure on (b)(6) 2024 and suture was used.During the procedure, it was reported by a sales rep that at the time of suture closure of vaginal stump, the needle was detached from the suture at the 2nd stitch.Another package was opened and used but the same thing happened again.These were not control release needles.Suture method was continuous suture.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: "it was reported that: ""at the time of suture closure of vaginal stump, the needle was detached from the suture at the 2nd stitch.Another package was opened and used but the same thing happened again"".* according to event description, it appears (b)(4) devices were affected, however, quantity of product involved was entered as (b)(4).Please confirm the number of devices affected during this procedure.= (b)(4).* please confirm the quantity of devices returning for analysis.= (b)(4).* two lots were provided: sdmqtq, sdmrdk.Please confirm the number of sutures affected per lot.= it could not be determined.* please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep)= (b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.= we regularly contact with sales rep about the device returning.Events reported via; (b)(4).

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18767007
• Report Number: 2210968-2024-01723
• Device Sequence Number: 12711522
• Product Code: NEW
• UDI-Device Identifier: 10705031048096
• UDI-Public: 10705031048096
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: PDP339H
• Device Lot Number: SDMRDK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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