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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL PWR HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVCE REPL PWR HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7209391S
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2018
Event Type  malfunction  
Event Description
It was reported that device works intermittently and overheats. No patient or user injuries were reported.
 
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. An evaluation was performed by the oem and no visual deficiencies were reported. Functional evaluation of the device by the oem found the unit got hot during testing. Troubleshooting by the oem found the motor to be bad and had been in the device since 2014. A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. The complaint was confirmed and per the oem the root cause was determined to be wear from use.
 
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Brand NameSVCE REPL PWR HIGH SPEED DRILL
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
jim gonzales
7000 w. william cannon drive
austin, TX 
MDR Report Key7377497
MDR Text Key103876219
Report Number3003604053-2018-00052
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7209391S
Device Catalogue Number7209391S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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