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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 2.9, MAG-MINI, DISP. BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ABRADER, 2.9, MAG-MINI, DISP. BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201518
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during the foot joint procedure, when the device was used, the center of the blade was broken. It is unknown if there were delays or a back up available. No patient harm was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameABRADER, 2.9, MAG-MINI, DISP. BLADE
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9980172
MDR Text Key192139262
Report Number1219602-2020-00668
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeJA
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 05/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2021
Device Model Number72201518
Device Catalogue Number72201518
Device Lot Number50718397
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
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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