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

Model Number	EM100-A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.The device was tested and the maximum temperature was measured to be 163°f.The likely cause was identified as inadequate preventative maintenance.It was also noted that the collet depth was out of spec.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.The preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device has been in use for approximately 64 months with no record of factory service during this period.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Repair request initiated for device with no reported malfunction.No patient impact reported.Repair request escalated to product event due to customer indication that this report is a complaint.On follow up, it was confirmed by the health care professional that the device was returned as it got very hot, there was no patient or user harmed.

• Brand Name: LEGEND EHS MOTOR
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 12016273
• Report Number: 1625507-2021-00171
• Device Sequence Number: 1375433
• Product Code: HBC
• UDI-Device Identifier: 10885074106486
• UDI-Public: 10885074106486
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K012456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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: EM100-A
• Device Catalogue Number: EM100-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1