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

Model Number	AS14-R
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report not confirmed for the attachment.Evaluation could not reproduce the reported malfunction of device stops intermittently.However, it was noted that the bearings were worn.This finding may have contributed to the user¿s experience.There were no anomalies found for the motor.No conclusion can be drawn for the tool (14mh30) as it was discarded.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 that the device was skipping and there was a dura cut to the patient.Upon follow-up it was confirmed that the patient did not require any additional non-routine interventions and there were no reported issues post surgery regarding the patient's current status.It was also reported that the 14mh30 drill was discarded by the hospital.

• Brand Name: 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: 8881386
• Report Number: 1625507-2019-00084
• Device Sequence Number: 10826611
• Product Code: HBB
• UDI-Device Identifier: 00763000172541
• UDI-Public: 00763000172541
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: AS14-R
• Device Catalogue Number: AS14-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/09/2019
• 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