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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
Catalog Number EMAX2PLUS
Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Event Description
It was reported from switzerland that during service and evaluation, it was determined that the motor device had the following failures: leak - air, heat, cannot secure/lock cutter, component damaged and device runs in locked position.It was further determined that the device failed pretest on visual assessment, cable assessment, cutter lock assessment, safety assessment, air pump assessment, and handpiece temperature assessment.It was noted on the service order that the device was spoiled.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 unknown but was noted to have occurred in (b)(6) 2023.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
 
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.Udi: (b)(4).The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.
 
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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 Key18655251
MDR Text Key334704623
Report Number1045834-2024-00139
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K080802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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 Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEMAX2PLUS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2024
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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