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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 Unintended System Motion (1430); Fail-Safe Problem (2936); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
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: the actual device was returned for evaluation.The motor device was evaluated and the reported condition that the device was not working was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device would run in the locked position and had unintended system motion.The assignable root cause of these conditions was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
 
Event Description
It was reported from india that during service and evaluation, it was determined that the motor device would run in the locked position, the cord was damaged, the device could not secure/lock the cutter, and had unintended activation/motion.It was further determined that the device failed pretest for visual assessment, cable assessment, cutter lock assessment, and safety assessment.It was noted 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 the event was not reported, however, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become 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
kate karberg
4500 riverside drive
palm beach gardens, FL 33410
3035526892
MDR Report Key14934189
MDR Text Key295694106
Report Number1045834-2022-00817
Device Sequence Number1
Product Code GEY
UDI-Device Identifier00845384002055
UDI-Public00845384002055
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K080802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
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 Manufacturer06/10/2022
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2015
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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