MAUDE Adverse Event Report: ETHICON INC. PDS+ CLR 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP422H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(4).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.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? as stated above, skin closure on back.What was used to complete the procedure? another suture from same box/batch.How many sutures were involved in this single procedure? i believe only one- small skin lesion removal.How many cases did this issue occur in on thursday, (b)(6) 2021? one.Device history lot: a manufacturing record evaluation was performed for the finished device batch qhmcbu, pdp422h and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a skin closure procedure on (b)(6) 2021 and suture was used.The suture broke during closure of back skin.Procedure was completed successfully with another like device.There were no adverse patient consequences reported.

• Brand Name: PDS+ CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11793767
• Report Number: 2210968-2021-04352
• Device Sequence Number: 11813056
• Product Code: NEW
• UDI-Device Identifier: 10705031048263
• UDI-Public: 10705031048263
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 04/12/2021

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: 06/30/2022
• Device Model Number: PDP422H
• Device Catalogue Number: PDP422H
• Device Lot Number: QHMCBU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1