MAUDE Adverse Event Report: SMITH & NEPHEW, INC., ENDOSCOPY DIVISION FAST FIX 360 CURVED NEEDLE DELIVERY SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202468

Device Problem Misfire (2532)

Patient Problem No Code Available (3191)

Event Date 10/30/2018

Event Type  malfunction  

Event Description

Pt in surgery for acl repair; arthroscopically aided anterior cruciate ligament reconstruction with patella tendon autograft and medial and lateral meniscus repair.Surgeon using a smith & nephew fast fix 360 curved needle delivery system when the system misfired.Surgeon discontinued usage of the device.Device taken out of service.Fda medwatch completed.

• Brand Name: FAST FIX 360 CURVED NEEDLE DELIVERY SYSTEM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC., ENDOSCOPY DIVISION; andover MA 01810
• MDR Report Key: 8046015
• MDR Text Key: 126638532
• Report Number: MW5081106
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: 72202468
• Device Lot Number: 50706962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 79