MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+ 1 70CM OS-8; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B204
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that a patient underwent a total knee replacement on (b)(6) 2018 and barbed suture was used to close the capsule.The suture barbs did not hold the tissue, so were pulling out.The procedure was completed with a competitive suture with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Used suture pieces and one empty opened foil of product were returned for analysis.During the visual inspection of the suture pieces, body fluids along of strands were found and the ends were cut appears to be by the use of a surgical instrument.Due to the condition of the samples no visual test could be performed to the barbs.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the suture pieces, it could not be determined what may have caused the reported issue of performance-barb non-engagement in tissue.

• Brand Name: STRATAFIX SPIRAL PDS+ 1 70CM OS-8
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7474297
• Report Number: 2210968-2018-72470
• Device Sequence Number: 128821
• Product Code: NEW
• UDI-Device Identifier: 10705031236004
• UDI-Public: 10705031236004
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2018

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: 11/30/2019
• Device Catalogue Number: SXPP1B204
• Device Lot Number: LPH741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/23/2018; 05/18/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/17/2018; 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1