MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A200
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was requested, but unavailable: 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.Trade name: (b)(4).Active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: 2360 g/m.Investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code sxpp1a200 was received for evaluation, the swage and attachment area was noted to be as expected.The needle was noted with marks that appear to be by use of the surgical instrument.The suture was examined along with the strand and some barbs present damage and body fluids.The fixation tab was broken at two sides and marks that appear to be by use of a surgical instrument could be observed.In addition, a side was returned for analysis, the piece was examined, and only was noted body fluid.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.
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on (b)(6) 2021 and barbed suture was used.When opening the package, it was found that the fixation tab had been broken.Upon evaluation of the returned device, it was noted that the fixation feature was broken during use.Additional information was requested.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11679584
• Report Number: 2210968-2021-03454
• Device Sequence Number: 11525611
• Product Code: NEW
• UDI-Device Identifier: 10705031227668
• UDI-Public: 10705031227668
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: SXPP1A200
• Device Catalogue Number: SXPP1A200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1