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

Model Number	PDP333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 size of the needle used? was more than half the needle retained in the patient? where is the needle retained; in what structure? are there plans to remove the retained needle piece? patient¿s current status? is the device or any samples available of evaluation? please provide facility contact person¿s name, mailing address and telephone.A shipper kit will be sent to help return the product to us.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.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
Per user facility medwatch form # 5099229.It was reported that a patient underwent a laparoscopic bladder sling procedure on (b)(6) 2021 and suture was used.During the surgery, the needle broke.The surgeon was not able to retrieve the piece that broke off.It remains in patient.It is unknown if the device is available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11613364
• Report Number: 2210968-2021-02990
• Device Sequence Number: 3499201
• Product Code: NEW
• UDI-Device Identifier: 10705031048065
• UDI-Public: 10705031048065
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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 Expiration Date: 10/31/2022
• Device Model Number: PDP333H
• Device Catalogue Number: PDP333H
• Device Lot Number: QMMHUJ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1