MAUDE Adverse Event Report: CONMED LARGO HALL; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO7000DE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device pro7000de, hall oralmax elite high-speed drill, was being used on (b)(6) 2025 and it ¿gets hot¿.There was no impact or injury for the patient or user.The surgery was completed with no delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the investigation of the device has not been completed.A supplemental and final report will be filed following the completion of the device complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device pro7000de, hall oralmax elite high speed drill, was being used on (b)(6) 2025 and it "gets hot".There was no impact or injury for the patient or user.The surgery was completed with no delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the device getting hot is unconfirmed.The device was overdue for preventative maintenance.The device was found to have a visual internal damage to the cast stator as well as collet and rotor failure due to bearings.The service history was reviewed and found similar repairs to this complaint.A device history record (dhr) review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised the following: 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 with proper performance.The oralmax elite high speed drills (pro7000de) shall be returned every 6 months for servicing.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.Bur guards should always be checked before use.To reduce the risk of injury, prior to surgery, spin the bur guard on a bur.If the bur guard spins freely, the bearing is still good.Otherwise, the bur guard must be sent for repair immediately.Do not use.Overheating can occur if bur guard bearings are worn or not kept clean.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: HALL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 21216899
• Report Number: 1017294-2025-00008
• Device Sequence Number: 3441999
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)210610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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 Catalogue Number: PRO7000DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic