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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS 2.0 MAG-MINI DISP. BLA SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS 2.0 MAG-MINI DISP. BLA SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201507
Device Problem Flaked (1246)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
One single disposable 2. 0mm full raduis mini magnetic abrader blade returned. The complaint stated: ¿the full radius blade produce metal debris when the oscillating button was press to start shaving the tissue. ¿ visual assessment confirms complaint. The inner blade showed flaking. An exact root cause cannot be determined with confidence. Per instructions for use: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance, and in extreme cases may result in wear and degradation of the inner blade¿. There were no indications that would suggest that the device did not meet product specifications upon release into distribution. A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found. Further investigation is not warranted at this time.
 
Event Description
It was reported that the full radius blade produce metal debris when the oscillating button was press to start shaving the tissue. The malfunction was solved using a back up device and no delays or further complications was reported.
 
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Brand NameFULL RADIUS 2.0 MAG-MINI DISP. BLA
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10341387
MDR Text Key200964121
Report Number1219602-2020-01150
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/06/2022
Device Catalogue Number72201507
Device Lot Number50779819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/29/2020 Patient Sequence Number: 1
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