MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ATTACHMENT MR8 VARIABLE ANGLED; MOTOR, DRILL, PNEUMATIC

Model Number	MR8-AVA12DK
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report confirmed.The device was tested and the max temperature was measured to be 142.4°f.It was also noted the device had oil/grease residue in the internal components.The likely cause was identified as the device was over-lubricated due to inadequate cleaning per ifu instructions.Device history record #217610922 was reviewed and did not reflect any conditions related to the current, reported malfunction.The device user manual warnings section includes instructions that 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 device user manual also includes instructions to properly clean all reusable devices prior to use.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 during a case, the device was overheating.It was also reported that a 12mh30 tool was used with the attachment.No patient impact was reported.On follow up, it was confirmed with the health care professional that there was no patient or staff impact.It was also reported that there was no issue with tool.

• Brand Name: ATTACHMENT MR8 VARIABLE ANGLED
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 12050877
• Report Number: 1625507-2021-00219
• Device Sequence Number: 3362267
• Product Code: HBB
• UDI-Device Identifier: 00643169975262
• UDI-Public: 00643169975262
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: MR8-AVA12DK
• Device Catalogue Number: MR8-AVA12DK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1