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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2017
Event Type  malfunction  
Manufacturer Narrative
One 7210976 disposable 4. 5mm incisor plus elite blade returned. The complaint was in regards to light metal residue. Visual inspection shows have flats worn onto a few teeth. There are light contact abrasion wear bands to the inner blade¿s od surface. This observance is attributed to inadvertent side load pressure and contact with a hard surface. Per the device ifu, ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿. And also ¿do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope. Damage to both instruments is likely. Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo. If such contact does occur, inspect the tip. If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately. ¿ no further investigation is warranted at this time. (b)(4).
 
Event Description
It was reported that the blade left a metal residue in the patient. All residue was removed from the patient and a backup device was available to complete the procedure.
 
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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 78735
MDR Report Key6599939
MDR Text Key76241619
Report Number1219602-2017-00563
Device Sequence Number1
Product Code HAB
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 05/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/21/2022
Device Catalogue Number7210976
Device Lot Number50643170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2017
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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