MAUDE Adverse Event Report: CONMED CORPORATION LINVATEC HIGH SPEED DRILL; DRILL, BONE, POWERED

Model Number 2060-025

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The doctor was doing teeth extractions for this patient and the high speed drill malfunctioned.It stopped working during drilling in patient's mouth, and got hot on surgeons hands that he couldn't hold on to it.The drill was taken out of service and removed immediately.

• Brand Name: LINVATEC HIGH SPEED DRILL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 14786875
• MDR Text Key: 295250413
• Report Number: 14786875
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

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
• Device Operator: Health Professional
• Device Model Number: 2060-025
• Device Lot Number: 0130845854023765
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1