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

Model Number	AD01
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	Sprain (2083)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device has not been returned from the facility.If the device is returned in the future, product analysis may be performed.We will continue to track and trend this complaint type.
Event or Problem Description
See information referenced in: 1625507-2017-00030 for initial details.A new device is included within this mdr.The facility requested to return the motor, however, it was identified the device held in risk management at the facility was an attachment and not a motor.In addition, it was the attachment which was held by the surgeon at the time of the incident.The serial number information was provided for the attachment.Risk management testing/analysis were requested; however, the facility would not provide the results.The facility requested a replacement attachment, and the return is pending.Additional follow up regarding status identified the surgeon took a four week leave of absence.No further information was provided.
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction of drill spun in the doctor's hand.The overall condition of the ad01 attachment was good.There was no obvious damage.Testing was conducted, and the device functioned normally.As soon as the perforator cut through the bone, the cutting edge of the tip stopped, but the ad01 was spinning.While using a firm grip, the motor did not spin in the tester¿s hand and was stable.The most probable cause for the reported event is that the facility user may not have held the device securely and the device may not have been positioned perpendicular to the skull.This technique may have contributed to the user¿s experience.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.

• Brand Name: MIDAS REX® PERFORATOR 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: 6916731
• Report Number: 1625507-2017-00034
• Device Sequence Number: 1444228
• Product Code: HBB
• UDI-Device Identifier: 00721902481925
• UDI-Public: 00721902481925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AD01
• Device Catalogue Number: AD01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/14/2017
• 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