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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7210976
Device Problem Metal Shedding Debris (1804)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
It was reported that metal shavings from the blade were spread over the joint. All shavings were removed from the joint and the procedure was completed with a backup device. No delay or patient impact were reported.
 
Manufacturer Narrative
Examination was not possible, as the device was not returned. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event with the clinical details provided. A review of the device history record was not possible due to a lot number not being provided. No further investigation is warranted at this time. (b)(4).
 
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Brand NameINCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
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
james gonzales
7000 west william cannon drive
austin, TX 
MDR Report Key6550795
MDR Text Key74793096
Report Number1219602-2017-00469
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7210976
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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