MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information: component code: g07002 - device not returned.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please provide the lot number:unk did the needle fall into the patient? not fell but when the needle-suture was inserted into the tissue, the suture was detached from the needle so the surgeon had difficulty removing the needle from the tissue but eventually was able to remove the needle.If yes, was the needle piece(s) retrieved during the same procedure? what tissue structure the needle was located? were x-rays taken to locate the needle? what measures were taken to retrieve the broken needle? was there any additional tissue damage as a result of searching for the needle? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sales rep about the device returning.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m all others.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.
Event or Problem Description
It was reported a patient underwent an unknown surgery on an unknown date and barbed suture was used.The needle-suture was inserted into the tissue, and when the needle was buried in the tissue, the surgeon tried to pull back the needle by holding the suture because the surgeon tried to restart suturing, the suture was detached from the needle easily.The surgeon had difficulty removing the needle from the tissue and eventually was able to remove the needle.Another product was opened and used, and the treatment was completed.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/21/2023 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.Additional information: d4, g1 additional information was requested, the following was obtained: lot number : unk => semrps the following additional information was received: during the surgery, the surgeon never lost track of the needle's position.
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.H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned sample.Visual analysis of the returned samples revealed that it was received one detached needle, a dispensed suture that pertained to product code pdp305h in order to evaluate the conditions of the detached needle, the swage area and hole were noted with marks by a surgical instrument.In the hole was observed a suture piece.In addition, the suture was examined and the end was noted to be cut probably caused by a surgical instrument.The instructions for use do contain the following caution: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: PDS+ VIO 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, SURGICAL, 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 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16663923
• Report Number: 2210968-2023-02303
• Device Sequence Number: 5933802
• Product Code: NEW
• UDI-Device Identifier: 10705031047983
• UDI-Public: 10705031047983
• 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,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 04/30/2024
• Device Model Number: PDP305H
• Device Catalogue Number: PDP305H
• Device Lot Number: SEMRPS
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 04/25/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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