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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 Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a knee scope procedure, metal shavings came off of the blade into the patient's knee joint. A backup device was utilized to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
Visual assessment of the blades shows tarnishing and there are no signs of shedding or flaking. Sliver plating is an s&n process used at the time of manufacture of these blades to improve lubricity and allow for friction free contact between the stainless steel inner and outer blades. The appearance of the "tarnish" and discoloration does not have any adverse effect on the performance of the device, procedure or patient. The tarnishing discoloration is a cosmetic issue only. A review of the device history record was performed which confirmed no inconsistencies. Device available for evaluation? yes.
 
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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
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5929490
MDR Text Key54484847
Report Number1219602-2016-00560
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number7205305
Device Lot Number50970649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2016
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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