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

Model Number	AA10
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report not confirmed for em200.Evaluation could not reproduce the reported malfunction as the temperature rise was within specification at 21°f.Report confirmed for aa10.The device was tested and the max temperature was measured to be 170°f.The likely cause was identified as inadequate preventative maintenance.It was also noted that the laser markings were faded and the color band was dented.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.The preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.The aa10 has been in use for approximately 74 months with no record of factory service during this period.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
Repair request initiated for device with the report of motor, cable and attachment were too hot handle and the motor has losing power.No patient impact reported.Repair request escalated to a product event based on reason for return and due to customer indication that this report is a complaint.It was also noted that the em200 product was returned in less than 90 days from purchase or repair.On follow-up, it was confirmed that there was no patient or staff impact.

• Brand Name: LEGEND 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: 12005416
• Report Number: 1625507-2021-00146
• Device Sequence Number: 19685880
• Product Code: HBB
• UDI-Device Identifier: 00721902481895
• UDI-Public: 00721902481895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: AA10
• Device Catalogue Number: AA10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2019
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1