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

Model Number	AS10S-R
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the sales rep that while dr.(b)(6) was using the midas ehs he quickly complained of chatter, soon followed by a tear in the dura.Dr (b)(6) was using the drill for burr holes in advance of the craniotomy, so he was already planning to expose and cut through the dura.After dr.(b)(6) did the initial bur hole, he switched attachments with the same tool and it worked as expected.There was a delay of approximately five minutes to open another tray.Some patient information was provided.Current status of the patient was not given, no patient impact reported.On multiple follow up attempts, no additional information could be obtained.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On further follow up it was reported the tool/attachment combo was different from what the surgeon was used to; the torn dura did not require any intervention since the surgeon had to remove the dura anyway; the patient has had no issues in regards to this event; and the user facilities initial reporters contact information was provided.

• Brand Name: MIDAS REX® LEGEND STRAIGHT 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: 7164015
• Report Number: 1625507-2018-00004
• Device Sequence Number: 1407841
• Product Code: HBB
• UDI-Device Identifier: 00613994421876
• UDI-Public: 00613994421876
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• 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,Followup
• Report Date (Section B): 02/06/2018

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: AS10S-R
• Device Catalogue Number: AS10S-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LEGEND TOOL 10MH30-MN LOT # H5395956
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR