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

Model Number	PM700
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Perforation (2001); No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported through medwatch report 0039-0111-2019-0002 that during a burr hole procedure, the drill did not stop automatically and went into the dura.No patient impact reported.Upon follow up, it was confirmed that there was no patient injury.There were no additional or unplanned actions/intervention used to complete the surgery except for computerized tomography (ctscan) which is a part of the post surgery procedure for the patient.No delay was also reported.The patient was discharged and in good condition.It was also reported that a perforator was used in the procedure and no additional information was provided on the model or serial number.No additional information has been provided about product return of the pm700 or perforator device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received confirming that ad03 perforator was used with the pm700.Information about product return is currently being requested.

• 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: 8504119
• Report Number: 1625507-2019-00022
• Device Sequence Number: 13740055
• Product Code: HBB
• UDI-Device Identifier: 00643169672499
• UDI-Public: 00643169672499
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM700
• Device Catalogue Number: PM700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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
• Patient Age: 42 YR