MAUDE Adverse Event Report: CONMED CORPORATION MICROPOWER ORAL MAX HIGH SPEED DRILL, DETACHABLE LEVER; ARTHROSCOPE

Catalog Number 00602002500

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 00602002500, was being used during a wisdom tooth extraction on (b)(6) 2020 when the device got hot and the patient received a 1st or 2nd degree burn on the lower lip while user was drilling bone.Further assessment questions were asked of the reporter; however, the degree of burn was not decided.The patient has had follow up and the lip is healing.There was no indication of medical intervention or hospitalization stated by the reporter.The procedure was completed as planned.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

Evaluation of the device found the hand piece running very rough and vibrated also making loud noise due to the rotor being jammed and stuck inside cast stator sleeve.The collet was corroded and a bearing frozen.Additionally, rust-like deposits were found on the outside of the collet and the pm is overdue.Parts were replaced, the device repaired, and the pm performed; the device was final tested and met all specifications.A device history record review was not conducted as the device has been in the field more than 12 months.The service history of the device was reviewed and found that the device had not received a preventative maintenance within the past 6 months.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 442 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: precautions: failure to follow the specified service interval could result in reduced instrument performance or overheating of the handpiece.Overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist wiht proper performance.Maintenance schedule: the micropower oral max high speed drills shall be returned every 6 months for servicing.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROPOWER ORAL MAX HIGH SPEED DRILL, DETACHABLE LEVER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10596556
• MDR Text Key: 209150148
• Report Number: 1017294-2020-00419
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K072706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00602002500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other