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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,4.0 ELITE ABRADER 6/BX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BLADE,4.0 ELITE ABRADER 6/BX SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200722
Device Problem Metal Shedding Debris (1804)
Patient Problems No Known Impact Or Consequence To Patient (2692); Test Result (2695)
Event Date 12/29/2017
Event Type  Malfunction  
Event Description

It was reported that the device shed metal shavings, all were removed from the patient. No significant delay or patient injury reported.

 
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.

 
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Brand NameBLADE,4.0 ELITE ABRADER 6/BX
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 Key7181796
MDR Text Key97092218
Report Number1643264-2018-00037
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200722
Device Catalogue Number72200722
Device LOT Number50664175
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 Received02/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2017
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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