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

Model Number	AVA14
Medical Device Problem Codes	Overheating of Device (1437); Physical Resistance/Sticking (4012)
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 temperature was measured to be 150.2°f.The rate of temperature rise was above threshold at 12.1°f/sec.The likely cause was identified as corroded internal tube bearing.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 overheating and will not rotate/frozen.It was reported that there was no patient impact.Repair request escalated to a product event based on reason for return.

• Brand Name: LEGEND ANGLED VAR 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: 11897976
• Report Number: 1625507-2021-00126
• Device Sequence Number: 14302785
• Product Code: HBB
• UDI-Device Identifier: 00763000085032
• UDI-Public: 00763000085032
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: AVA14
• Device Catalogue Number: AVA14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1