MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A400

Device Problem Needle, separation (1415)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

It was reported that the patient underwent subtotal gastrectomy on (b)(6) 2015 and barbed suture was used.While suturing the fascia, the needle came off after 3 passes into the tissue.The surgeon removed the barbed suture that had already been stitched, as it could not be secured in place without the needle.A like device was used and the fascia was closed with no further issue.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

• Brand Name: STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4848102
• MDR Text Key: 5875009
• Report Number: 2210968-2015-07123
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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