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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE STONECUTTER BURRS SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200729
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 06/29/2018
Event Type  Malfunction  
Manufacturer Narrative

Examination is not possible, as the device will not be returned. The investigation could not draw any conclusions about the reported event without the return of the device. Further investigation is not warranted at this time.

 
Event Description

It was reported that the device was shedding. There were no delays or patient injuries reported.

 
Manufacturer Narrative

Examination is not possible, as the device will not be returned. The investigation could not draw any conclusions about the reported event without the return of the device.

 
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Brand NameDYONICS 5.5MM ELITE STONECUTTER BURRS
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
5123585706
MDR Report Key7725226
MDR Text Key115185501
Report Number1219602-2018-00951
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,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200729
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
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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