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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200729
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.
 
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Brand Name
DYONICS 5.5MM ELITE STONECUTTER BURR
Type of Device
SAW, 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 Key7723640
MDR Text Key115367017
Report Number1219602-2018-00946
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 company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 07/02/2018
Initial Date FDA Received07/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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