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

Model Number EM100-A

Device Problems Overheating of Device (1437); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Repair request initiated for device with the report of overheating, noisy and damaged internal mechanism.No patient impact reported.Repair request escalated to a product event based on reason for return.On follow-up, no further information can be provided regarding the event and patient impact.

Manufacturer Narrative

Report confirmed.The device was tested and the max temperature was measured to be 142°f.The likely cause was identified as damaged internal mechanism.It was also noted that it was noisy.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.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOTOR LEGEND EHS
• Type of Device: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 12611413
• MDR Text Key: 282095235
• Report Number: 1625507-2021-00322
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 10885074106486
• UDI-Public: 10885074106486
• Combination Product (y/n): N
• PMA/PMN Number: K012456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 08/11/2021
• Date Manufacturer Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1