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

Model Number	AD03
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the perforator attachment continues to run while it was not confirmed for the motor.The likely cause was identified as worn bearing.It was also noted that the attachment's front housing was scratched and the laser markings were faded, the motor bearings were worn and it overheated with a temperature rise of 29.9°f but it was within specification and below threshold.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.Concomitant product: em200-r.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the case, the ad03 device didn't stop when it was supposed to.It could have hit the derma layer but a hematoma prevented that from happening.No patient impact was initially reported.On follow-up it was confirmed that the hematoma was present before the operation and was the indication for the procedure.There was no patient/staff impact or delay due to the said malfunction.
Additional Manufacturer Narrative
Additional follow up of analysis result of ad03 device determined that evaluation could not reproduce the reported malfunction of continues to run.It was noted that the bearing was worn.It was also noted that attachment's front housing was scratched and the laser markings were faded.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LEGEND 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: 7970017
• Report Number: 1625507-2018-00059
• Device Sequence Number: 16537008
• Product Code: HBB
• UDI-Device Identifier: 00613994418876
• UDI-Public: 00613994418876
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AD03
• Device Catalogue Number: AD03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1