MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 CURVED NDL DELIVERY SYS; SAW, POWERED, AND ACCESSORIES

Model Number 72202468

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Event Description

It was reported that the device pre-deployed the anchors before the doctor manually deployed.No patient injury was reported.

Manufacturer Narrative

One (b)(4) curved needle delivery system was returned for evaluation.Visual assessment of the device shows the actuator is in its post t2 deployment position indicating a complete deployment.No ts or suture were returned for evaluation.The device was functionally tested for proper actuator advancement and cycling and was found to function as intended.The condition of the device indicates that the trigger was manually advanced during deployment of t1 causing the premature deployment of t2.No root cause related to the manufacturing process can be established.

• Brand Name: FAST-FIX 360 CURVED NDL DELIVERY SYS
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7405776
• MDR Text Key: 104819078
• Report Number: 1219602-2018-00420
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554023077
• UDI-Public: (01)00885554023077(17)201121(10)50698474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/21/2020
• Device Model Number: 72202468
• Device Catalogue Number: 72202468
• Device Lot Number: 50698474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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