MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+ 3-0 30CM PS-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPP1B104

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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 that a patient underwent a reconstruction operation using flap on an unknown date and a barbed suture was used.During continuous suturing on the fascia, the surgeon felt the barbs on the suture were not caught on the tissue firmly.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: (b)(4).A dispensed needle-suture combination and one empty labeled winding former was received for analysis.During the visual inspection of the sample, the swage and attachment area were as expected.The suture was examined along the strand and body fluid were noted and the first and second loop of the suture was cut.Also, damage that appears be by use of surgical instrument was observe on the strand.Due to the sample condition, the assignable cause of barb non-engagement in tissue, was suggests an improper handling of the sample.

• Brand Name: STRATAFIX SPIRAL PDS+ 3-0 30CM PS-2
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON, INC. SAN LORENZO; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7534489
• MDR Text Key: 108998235
• Report Number: 2210968-2018-72970
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: 10705031236240
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1B104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1