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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER SAGITTAL SAW SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWER SAGITTAL SAW SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205786
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was received and sent to the original equipment manufacturer (oem) for evaluation. There was a relationship found between the returned device and the reported incident. Evaluation of the device by the oem found the unit did not run. When disassembled it was found that the motor had failed and the lohet was cracked. The complaint was confirmed and per the oem the root cause was determined to be wear from use.
 
Event Description
It was reported the device does not work at all times when the handle is pressed. Sometimes though, it will stay permanently on even when switched to safe mode. No injuries or complications were reported as a result.
 
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Brand NameDYONICS POWER SAGITTAL SAW
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 w william cannon drive
austin, TX 78735
MDR Report Key6802659
MDR Text Key138086079
Report Number1643264-2017-00478
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,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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