MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A405

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Attempts to obtain the device have been made.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.

Event Description

It was reported during a product demonstration of new product on an unknown date in (b)(6) 2019 barbed suture was used.It was found when the packaging was opened, there was wrong product inside.Suture wit a spiral barb was inside where a symmetric barb should have been.No patient involvement/consequences.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/23/2020.Additional information: d10, h6.Additional h3 investigation summary: only pictures were returned for analysis.Upon visual inspection of the pictures, an open sample including a stratafix spiral suture, along with a winding former, paper lid and the foil primary package from a startafix symmetric can be observed.In addition, a retained sample was opened and no mixed product was observed.It should be noted that stratafix spiral suture product seen in the pictures corresponds to product that is manufactured at the san lorenzo puerto rico site, whereas the packaging components within the picture correspond to stratafix symmetric product that is manufactured in the juarez mexico site.As the suture and packaging material are not available at the same site, no conclusion could be reach on what could have caused the reported event.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Additional h3 investigation summary: an empty opened foil and an open labeled winding former with a re-winding needle/suture combination of product code sxpp1a405, lot # pdz994 were received for evaluation.During the visual inspection of the sample, the strand belongs to stratafix spiral suture and the paper lid and the foil package from a startafix symmetric.In addition, a retained sample was opened, and no mixed product was observed.It should be noted that stratafix spiral suture product is manufactured at the san lorenzo puerto rico site, and the packaging components correspond to stratafix symmetric product that is manufactured in the juarez mexico site.Therefore, the product could not be mixed our manufacturing process.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9532834
• MDR Text Key: 194126483
• Report Number: 2210968-2019-91404
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: 10705031227682
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: SXPP1A405
• Device Catalogue Number: SXPP1A405
• Device Lot Number: PDZ944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 12/30/2019
• Patient Sequence Number: 1