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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72203013
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2017
Event Type  malfunction  
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.
 
Event Description
It was reported that the shaver started shedding shavings, the shavings were suctioned out. No patient injury or harm was reported.
 
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Brand Name4.5MM INCISOR PLUS PLATINUM 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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6978577
MDR Text Key143965450
Report Number1219602-2017-01336
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010655660
UDI-Public(01)03596010655660(17)220607(10)50668342
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Model Number72203013
Device Catalogue Number72203013
Device Lot Number50668342
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 Received10/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2017
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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