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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS EMAX 2 MOTOR ASSEMBLY; MOTOR, DRILL, ELECTRIC - HANDPIECE Back to Search Results
Catalog Number EMAX2
Device Problems Loose or Intermittent Connection (1371); Defective Device (2588); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Udi: gtin is unavailable as the product made prior to compliance date; (b)(4).Initial reporter's phone number: (b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported from (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring was damaged, motor and control were defective, connector sleeve was loose and hose was worn on the motor device.The device also failed the following pre-tests: loctite and cable, temperature and hand control.It was reported in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
EMAX 2 MOTOR ASSEMBLY
Type of Device
MOTOR, DRILL, ELECTRIC - HANDPIECE
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens FL 33410
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
rodney crain
4500 riverside drive
palm beach gardens, FL 33410
5616271080
MDR Report Key5869841
MDR Text Key52896052
Report Number1045834-2016-12431
Device Sequence Number1
Product Code HBC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K011444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 06/22/2016
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/27/2016
Initial Date FDA Received08/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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