MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 4-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP315H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device not returned.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.The following information was requested, but unavailable: what was the procedure date? what is the lot number? was the suture placed interrupted or continuous stitch? how many knots were placed in the suture? did the operating surgeon observe any suture deficiency or anomaly before or during placement? was the re-suturing performed? when? could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? was there any adverse consequence associated with the patient? what is the current condition of the patient? i asked surgeon if he had any other information he could share on this inquiry and said ¿no¿.This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent a thoracic surgery in 2021 and suture was used.Post-operatively, the suture broke.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS+ VIO 27IN 4-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12226450
• Report Number: 2210968-2021-06672
• Device Sequence Number: 4136645
• Product Code: NEW
• UDI-Device Identifier: 10705031048010
• UDI-Public: 10705031048010
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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 Model Number: PDP315H
• Device Catalogue Number: PDP315H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1