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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. FAST-FIX 360 CURVED NDL DELIVERY SYS SAW, POWERED, AND ACCESSORIES Back to Search Results
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.

 
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Brand NameFAST-FIX 360 CURVED NDL DELIVERY SYS
Type of DeviceSAW, 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 Key7512804
MDR Text Key108258001
Report Number1219602-2018-00591
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK092508
Number of Events Reported1
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 Received05/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number72202468
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 Received05/02/2018
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

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