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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problems Display or Visual Feedback Problem (1184); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
Event Type  malfunction  
Event Description
It was reported that the shaver handpiece stopped oscillating and the control unit showed the message: handpiece motor fault. Hand piece felt warm. There was no injury reported or significant delay. Back up was available to complete the procedure.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. A relationship, if any, between the subject device and the reported event could not be determined. No containment or corrective actions are recommended at this time. A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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Brand NameMOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
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 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key7794169
MDR Text Key117723934
Report Number1643264-2018-00615
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616
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 Received09/18/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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