MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A407
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot number qmmczl and no non-conformances related to the reported complaint condition were identified.Investigation summary: visual analysis of the returned product revealed that one opened sample product code sxpp1a407 was received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was to be damaged at the surface, body fluids and the barbs were to be damaged at the tips.In addition, the end was observed broken.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.The product code sxpp1a407 contains absorbable suture, as the sample was received open, the time of exposure to the environment could not be determined and a functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 ¿g/m.Note: event reported in 2210968-2021-09603.
Event or Problem Description
It was reported that a patient underwent a robotic incisional hernia procedure on (b)(6) 2021 and a barbed suture was used.During the procedure, near the end of the continuous suture run, the surgeon using the ¿shoelace affect¿, while tightening the suture, the surgeon pulled hard and the suture broke.Another like device was used to complete the procedure.There were no adverse consequences for the patient.No additional information was provided.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 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: 12624866
• Report Number: 2210968-2021-09602
• Device Sequence Number: 11659090
• Product Code: NEW
• UDI-Device Identifier: 10705031227644
• UDI-Public: 10705031227644
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: SXPP1A407
• Device Catalogue Number: SXPP1A407
• Device Lot Number: QMMCZL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1