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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS EMAX 2 HAND CONTROL; MOTOR, DRILL, ELECTRIC - HAND CONTROL

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DEPUY SYNTHES POWER TOOLS EMAX 2 HAND CONTROL; MOTOR, DRILL, ELECTRIC - HAND CONTROL Back to Search Results
Catalog Number EMAX2-HC
Device Problems Mechanical Problem (1384); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that during an unspecified surgical procedure of the spine it was observed that the hand control device was not working with the motor device.It was reported that there was a five minute delay in the procedure as an identical spare hand control device was available for use.It was reported that the procedure was successfully completed.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
EMAX 2 HAND CONTROL
Type of Device
MOTOR, DRILL, ELECTRIC - HAND CONTROL
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer Contact
rodney crain
4500 riverside drive
palm beach gardens, FL 33410
5616271080
MDR Report Key6116471
MDR Text Key60865162
Report Number1045834-2016-13275
Device Sequence Number1
Product Code HBC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEMAX2-HC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/04/2016
Initial Date FDA Received11/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
MOTOR DEVICE
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