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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 Problem Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/07/2018
Event Type  malfunction  
Event Description
It was reported that drill would not shut off.A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.A functional test revealed the device was recognized by the controller but the motor would not activate.The complaint reported that the drill would not shut off was not verified.A review of the device history records showed there were 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 Name
SVCE REPL PWR HIGH SPEED DRILL
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7547775
MDR Text Key109461540
Report Number3003604053-2018-00081
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010498014
UDI-Public(01)03596010498014
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7209391S
Device Catalogue Number7209391S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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