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	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: could you please confirm how many procedures were affected and how many devices involved during each one? i can confirm, this happen in two cases.One of the surgeons, dr mcintosh, told me in his case, 2 broke.He said this was the 2nd time it happen to him.Dr urban, which was my first complaint in this sequence, had one break.Did 4 sutures broke during the ventral hernia procedure being reported in (b)(4) dr (b)(6), told me he had 2 break in 2 different cases.He did not have any product or lot to provide, but i was able to find the box it was pulled from and it matched dr urban's lot#.Did the sutures snapped during use on the patient or upon handling/dispensing before use on the patient? please specify.Both surgeons described being mid way suturing the defect closed and when they tighten down, the sutures broke.Both said it broke in the middle of the suture.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(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 a ventral hernia repair procedure on (b)(6) 2021 and barbed suture was used.During the procedure, it was reported by the rep during a ventral hernia procedure as the surgeon pulled down on the suture it snapped in the middle.The procedure was completed with another like device from a different lot.No adverse patient consequences were reported.Additional information was requested.

• 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: 11801271
• Report Number: 2210968-2021-04411
• Device Sequence Number: 4634822
• Product Code: NEW
• UDI-Device Identifier: 10705031227644
• UDI-Public: 10705031227644
• Combination Product (Y/N): Y
• 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): 04/15/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1