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

Catalog Number SXPP1B420

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Actual sample was received for evaluation.During the visual inspection of the suture pieces, it was observed body fluids along of the strands and the ends were cut.Also, the barbs were present on the suture pieces; however, the barbs could not be measured since the samples are an absorbable suture and was returned opened, the degradation process already has begun resulting in a damaged suture.According to the sample condition, it could not be determined what may have caused the reported incident.

Event Description

It was reported that the patient underwent a sleeve gastrectomy procedure on (b)(6) 2017 and the barbed suture was used.During the procedure, a surgeon noticed that the barbed suture did not have many barbs on the suture.The procedure was completed with another like device and there were no patient consequences reported.No further information is available.

• Brand Name: STRATAFIX SPIRAL PDS PLUS
• 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 PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6745146
• MDR Text Key: 81137800
• Report Number: 2210968-2017-33135
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: SXPP1B420
• Device Lot Number: LAH759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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