MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what was being done when the suture broke (e.G.Removal from package, during passage through tissue, during tying, post-op, etc.)? during closing the surgical wound with the suture.What tissue was being approximated or sutured when it broke? no further information is available.Could you please provide lot number? no further information is available.No further information will be provided.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.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.Note: events reported via: (b)(4).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 orthopedic procedure on (b)(6) 2021 and barbed suture was used.During the procedure, two (2) sutures broke in a row during wound closure though they were used with the usual way.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFX SYM PDS+ UNI 18IN 3-0 SA PS-2 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11509660
• Report Number: 2210968-2021-02435
• Device Sequence Number: 4497357
• Product Code: NEW
• UDI-Device Identifier: 10705031227743
• UDI-Public: 10705031227743
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: SXPP1A101
• Device Catalogue Number: SXPP1A101
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1