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

Catalog Number 72202468

Device Problem Activation, Positioning or SeparationProblem (2906)

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

Event Date 05/02/2018

Event Type  Malfunction  

Event Description

It was reported that t2 anchor did not deploy. It came out of the meniscus. No patient injury was reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device. Further investigation is not warranted at this time.

• 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: 7512804
• MDR Text Key: 108258001
• Report Number: 1219602-2018-00591
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: K092508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,FOREIGN,HEALTH PR
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/14/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: 72202468
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2018
• 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