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

Model Number	PM700-R
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction as the temperature was within specification at motor 90°f and the collet 95°f.It was also noted motor lubricant seal was leaking air.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
It was reported the pm700 motor severely overheated and burned the patient.The event date was reported to be (b)(6) 2017.The burn was described as not severe.The physician's name and the or manger's name and phone number were provided.

• Brand Name: MIDAS REX PNEUMATIC MOTOR
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 7156126
• Report Number: 1625507-2017-00043
• Device Sequence Number: 16616400
• Product Code: HBB
• UDI-Device Identifier: 00613994503787
• UDI-Public: 00613994503787
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K090112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PM700-R
• Device Catalogue Number: PM700-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other