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

Model Number	EM100-A
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Repair request initiated for device with the report of not working.No patient impact reported.Repair escalated to a product event on evaluation due to overheating.Additional information regarding the patient impact was being followed up from the facility.
Additional Manufacturer Narrative
Report confirmed.The device was tested and the maximum temperature was measured to be 139°f.The likely cause was identified as worn front and rear bearings.It was also noted collet laser markings were faded.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.This report is not a complaint as there is no allegation of deficiency or serious injury.This is a repair request that was escalated for evaluation of reportability.It was determined this is not a reportable event and will be handled as a routine repair request.If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 14081285
• Report Number: 1625507-2022-00064
• Device Sequence Number: 13977395
• Product Code: HBC
• UDI-Device Identifier: 00763000096632
• UDI-Public: 00763000096632
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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 Sex: Unknown