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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205305
Device Problem Material Discolored (1170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2019
Event Type  malfunction  
Event Description
It was reported that during a knee procedure, it was noticed that the tip of the blade was black. There was no delay or patient injuries but, it is unknown how the procedure was finished since no backup device was available to complete it. Attempts were made to retrieve further details about the event but the complainant does not have more information.
 
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Brand NameFULL RADIUS BLADE,3.5MM,DISP
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
5123585706
MDR Report Key8726465
MDR Text Key148947245
Report Number1219602-2019-00739
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205305
Device Lot Number50731902
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2018
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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