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

Model Number	PM710
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Perforation (2001)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction.However, it was noted that a ferrule was loose which would not cause or contribute to the event.The motor did not malfunction.Control of the tool within the motor should be maintained throughout use in a procedure.Appropriate precaution should be undertaken to protect surrounding tissue.The likely cause of the damage to the dura is a human factors issue.The 14mh30 (lot number unknown) dissecting tool was discarded by the facility and not returned for analysis.The user manual contains the following warning: surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability.We will continue to track and trend this complaint type.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the motor did not stop spinning when the surgeon took the hand off the hand control.The patient had a dura tear, because the motor would not stop spinning.On follow up, it was reported the patient was required to stay overnight due to the csf leak and for monitoring.The patient has since been discharged, but the current condition is unknown.There was no additional patient information available.The surgical procedure was a laminotomy (spinal surgery - no fusion).The initial reporter information and partial concomitant device information was also provided.On further follow up with the doctor, it was reported the patient was well postoperative.The dura leak was addressed with no patch used.

• 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: 6606343
• Report Number: 1625507-2017-00023
• Device Sequence Number: 16396377
• Product Code: HBB
• UDI-Device Identifier: 00613994486257
• UDI-Public: 00613994486257
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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: PM710
• Device Catalogue Number: PM710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/01/2017
• 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: Hospitalization