MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A SH CR; SUTURES - ABSORBABLE

Catalog Number	PDP773D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Events reported: (b)(4).
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, it was reported that the suture was broken when the surgeon attempted to sew the tissue.Changed another suture from the same pouch to continue the surgery, the same problem happened.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/2/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample revealed that it was received one winding former with five detached needles and three needle-suture pieces and one empty opened foil and pertain to the product code pdp773d.The product code is a control release and required eight strands per packet.In order to evaluate the conditions of the returned sample, the suture piece was observed with the end cut.Body fluids and crimping marks on the surface of the suture that was possibly caused by a surgical instrument.The condition of the samples received indicates improper handling of the device and no functional test was performed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related reports: 2210968-2023-04661.

• Brand Name: PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A SH CR
• Common Device Name: SUTURES - 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: 17210239
• Report Number: 2210968-2023-04660
• Device Sequence Number: 17809144
• Product Code: NEW
• UDI-Device Identifier: 10705031218765
• UDI-Public: 10705031218765
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/02/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: PDP773D
• Device Lot Number: SDMQMJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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