MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LC EMAX 2 PLUS MOTOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	EMAX2PLUS
Medical Device Problem Codes	Device Alarm System (1012); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional 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.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.H10 additional narrative: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that the motor device was displaying an e6 error code (overheat warning) and the device did not work, even when the foot switch was pressed.It was not reported if the device was used in a surgical procedure, or if a spare device was available for use.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 2026.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional 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.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.H10 additional narrative: corrected: d9, h3.A visual and functional assessment was performed on the device.The following steps failed: visual assessment.Cable assessment.No short circuit between phases and connector body.No short circuit between hall sensors and connector body.No short circuit between 5vdc line and connector body.No short circuit between sensor gnd and connector body.During service/repair the following was observed (technician note): pre-internal comment: ng (failure), not reproducible, hose damaged, connector loose, cap wire frayed, leakage evaluation ng (failed).Post-internal comment: ok.Action taken: hose replacement, cutting-bar gripping part replacement, motor replacement, motor flex replacement, housing replacement, bearing replacement, internal parts replacement, consumable parts replacement.During the service evaluation the following failures were identified: functional : loose.Visual : breaded stainless steel wire tether damage/came off.Visual : cord damaged.Internal finding : damaged flex circuit.Conclusion: failure reported is not confirmed.Root cause: faulty parts (3210).Action: repair.

• Brand Name: EMAX 2 PLUS MOTOR
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 24478980
• Report Number: 1045834-2026-00059
• Device Sequence Number: 10255219
• Product Code: HBE
• UDI-Device Identifier: 00845384002055
• UDI-Public: (01)00845384002055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1930-2017 THRU Z-2032-
• Patient Sequence Number: 1
• Patient Sex: Unknown