MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B421
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a tramm flap procedure on (b)(6) 2018 and a barbed suture was used.During the procedure, the surgeon noted that the barbs were at very low profile and the suture was with a monofilament suture hand feeling.During suturing, the surgeon found that the anchors could not secure the suture firmly with the tissue therefore the suture could be pulled backward extremely easily.The procedure was completed with a different device.There were no adverse patient consequences reported.No additional information was available.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: an empty opened foil, a labeled winding former with a needle/suture combination were returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected.The suture was examined, and the barbs were present along of the strand.The barbs were measured and all barbs met with the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, no performance barb non-engagement in tissue was found on the sample.

• Brand Name: STRATAFIX SPIRAL PDS+
• 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: 7864617
• Report Number: 2210968-2018-75774
• Device Sequence Number: 16781068
• Product Code: NEW
• UDI-Device Identifier: 10705031235922
• UDI-Public: 10705031235922
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 05/31/2019
• Device Catalogue Number: SXPP1B421
• Device Lot Number: LGH311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1