MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MOTOR MR8 ELECTRIC; MOTOR, DRILL, ELECTRIC

Model Number	EM810
Medical Device Problem Codes	Loss of Power (1475); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cranioplasty for cranial vault reconstruction procedure, both em810s were wanting to be used as just a foot control drill and ipc read error code 18- wanting finger lever to be reseated.Doctors did not want to use finger lever.Ipc was marked for ¿foot¿.When foot pedal was engaged, ipc would jump from finger/foot and safe/ on and drill bit would only spin intermittently and then give error code.We placed a finger lever on drill and docs used as foot control with lever on.Error code continued to come up but drill would work after pressing ok.No patient impact reported.It was also reported that there was an intervention performed, no damaged piece remained in the patient's body, and there was 30 mins delay in procedure.The procedure was completed with reported product(s).
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that the device was tested, and the temperature was measured to be 150.5f.The likely cause of failure was identified as inadequate preventive maintenance.It was also noted that error code 18 displayed, motor shutdown when it was running and shaft broken.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
B5: corrected the patient details in event description.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a cranioplasty for cranial vault reconstruction procedure, both em810s were wanting to be used as just a foot control drill and ipc read error code 18- wanting finger lever to be reseated.Doctors did not want to use finger lever.Ipc was marked for ¿foot¿.When foot pedal was engaged, ipc would jump from finger/foot and safe/ on and drill bit would only spin intermittently and then give error code.We placed a finger lever on drill and docs used as foot control with lever on.Error code continued to come up but drill would work after pressing ok.No patient impact reported.It was also reported that there was an intervention performed, no damaged piece remained in the patient's body, and there was 30 mins delay in procedure.The procedure was completed with reported product and the patient was alive with no injury.

• Brand Name: MOTOR MR8 ELECTRIC
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21330154
• Report Number: 1625507-2025-00130
• Device Sequence Number: 20987802
• Product Code: HBC
• UDI-Device Identifier: 00643169912113
• UDI-Public: 00643169912113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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 Model Number: EM810
• Device Catalogue Number: EM810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Sex: Female
• Patient Weight: 9 KG