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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC EMAX 2 PLUS MOTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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DEPUY SYNTHES PRODUCTS LLC EMAX 2 PLUS MOTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Model Number EMAX2PLUS
Device Problems Environmental Particulates (2930); Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition of smoke was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was confirmed that the device had excessive noise and overheated.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
 
Event Description
It was reported that during a preventative maintenance, it was discovered that the motor device produced a high pitch sound when performing a drill test.It was further reported that when the attachment device was removed from the drill device and retested while holding the pedal down for roughly 60 seconds, the high pitch sound occurred again and the drill started smoking.During in-house engineering evaluation, it was determined that the motor device had locking components damaged, excessive noise, 360 degree rotation, cable damaged, heat and missing components.It was further determined that the device failed pretest for cable assessment, noise assessment and handpiece temperature assessment.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name
EMAX 2 PLUS MOTOR
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
4500 riverside drive
palm beach gardens FL 33410
Manufacturer Contact
kara ditty-bovard
4500 riverside drive
palm beach gardens, FL 33410
6107428552
MDR Report Key11706562
MDR Text Key257695481
Report Number1045834-2021-00622
Device Sequence Number1
Product Code GEY
UDI-Device Identifier00845384002055
UDI-Public00845384002055
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080802
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
Report Date 03/05/2021
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 Model NumberEMAX2PLUS
Device Catalogue NumberEMAX2PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Initial Date Manufacturer Received 04/09/2021
Initial Date FDA Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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