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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.

 
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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 Key7547775
MDR Text Key109461540
Report Number3003604053-2018-00081
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 10/12/2018
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
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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