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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205314
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  malfunction  
Event Description
It was reported that while the joint was being cleaned it was noticed that the blade was releasing metal particles, and these spread throughout the joint. The procedure was completed with the same device. 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.
 
Manufacturer Narrative
One 5. 5mm (b)(4) blade was returned for evaluation. Visual assessment of the device showed visible signs of material galling and debridement on the inner blade confirming the reported shedding. The outer blade is bent. The condition of the device indicates the blade was subjected to excessive side-loading during use.
 
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Brand NameINCISOR, 5.5MM,EP-1,DSPL 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 Key7339775
MDR Text Key102586732
Report Number1219602-2018-00336
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2022
Device Model Number7205314
Device Catalogue Number7205314
Device Lot Number50660058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2017
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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