MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number	AF02R
Medical Device Problem Codes	Overheating of Device (1437); Difficult to Remove (1528); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary # report confirmed.The device was tested and the temperature was measured to be 303°f.However, the rate of temperature rise was below threshold.The likely cause was identified as corroded bearings.It was also noted that the attachment don't run, color band and laser markings were faded and illegible, burr was very difficult to remove and noisy and the leg was damaged.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.
Event or Problem Description
Repair request initiated for device with the report of attachment stuck.It was reported that there was no patient involvement.Repair request escalated to product event due to customer indication that this report is a complaint.Additional information received, reason for return were overheating and noise.

• Brand Name: MIDAS REX LEGEND ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 12008575
• Report Number: 1625507-2021-00153
• Device Sequence Number: 3304150
• Product Code: HBB
• UDI-Device Identifier: 00763000084745
• UDI-Public: 00763000084745
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020069
• 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): 06/16/2021

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: AF02R
• Device Catalogue Number: AF02R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1