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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ABRADER BURR SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ABRADER BURR SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200723
Device Problem Metal Shedding Debris (1804)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the dyonics 5. 5mm elite abrader burr was shedding metal from the device. A backup device was readily available. There was a delay of less then 30 minutes. No patient injuries were reported.
 
Manufacturer Narrative
Device investigation narrative - examination was not possible, as the device has not been returned. The investigation was limited to the information provided; the investigation could not draw any conclusions about the reported event without the return of the device in question. Further investigation is not warranted at this time.
 
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Brand NameDYONICS 5.5MM ELITE ABRADER BURR
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
MDR Report Key6659772
MDR Text Key78252758
Report Number1219602-2017-00646
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200723
Device Lot Number50621374
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 Received05/30/2017
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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