MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDPB340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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: please provide lot number.No further information is available.How was procedure successfully completed? no further information is available.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 an unknown orthopedic procedure on an unknown date and suture was used.During the procedure, the suture broke while ligating the fascia.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12583743
• Report Number: 2210968-2021-09252
• Device Sequence Number: 3907769
• Product Code: NEW
• UDI-Device Identifier: 10705031048799
• UDI-Public: 10705031048799
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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 Model Number: PDPB340
• Device Catalogue Number: PDPB340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1