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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 Output below Specifications (3004); Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
It was reported from china that during service and evaluation, it was determined that the motor device had the following failure: device runs in locked position.It was further determined that the device failed pretest on safety assessment.It was noted on the service order that the device had low power issue before an unknown surgery.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 2023.All available.
 
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.H10 additional narrative: udi: (b)(4).The actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device having low power issue was not confirmed.Therefore, the assignable root cause was not determined.However, the malfunctions found during service and evaluation have been 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 Key18949793
MDR Text Key338453259
Report Number1045834-2024-00314
Device Sequence Number1
Product Code GEY
UDI-Device Identifier84538400205
UDI-Public84538400205
Combination Product (y/n)N
Reporter Country CodeCH
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 Received03/21/2024
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 Manufacturer03/14/2024
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2020
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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