MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI 18IN 3-0 SA PS-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A100
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
Product complaint number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: what is the procedure & event date? =>no further information is available.What was used to complete the procedure? =>no further information is available.What is the 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.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 procedure on an unknown date and barbed suture was used.During the procedure, the suture broke.There were no patient consequences reported.Additional information was requested.

• Brand Name: SFX SYM PDS+ UNI 18IN 3-0 SA PS-1 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13577940
• Report Number: 2210968-2022-01222
• Device Sequence Number: 4409816
• Product Code: NEW
• UDI-Device Identifier: 10705031227736
• UDI-Public: 10705031227736
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: SXPP1A100
• Device Catalogue Number: SXPP1A100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown