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	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the pro7000de, hall oralmax elite high speed drill was used in an unnamed procedure on an unknown date and became ¿noisy and hot¿.The procedure was completed with a ¿new handpiece¿, and with no delay ¿except to get the alternate device¿, which was nearby.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.The customer was unable to provide further details about the event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A customer reported that the pro7000de, hall oralmax elite high speed drill was used in an unnamed procedure on an unknown date and became ¿noisy and hot¿.The procedure was completed with a ¿new handpiece¿, and with no delay ¿except to get the alternate device¿, which was nearby.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.The customer was unable to provide further details about the event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: the date in block b.3 has been removed, as it had been entered in error.Reported event of ¿tool overheating¿ was confirmed.The evaluation found that the preventative maintenance was not overdue.Additional problems were found.The rotor assembly was serviced.Additional parts serviced were the compression spring, the o-ring, the collet assembly, and the cast stator assembly.A root cause cannot be determined; however, based upon the risk analysis, a possible cause of this event could be bearing failure.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and found similar problem repairs to this complaint.A two-year review of complaint history revealed there has been a total of 77 reports, regarding 77 devices, for this device family and failure mode.During this same time frame (b)(4) 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 to 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.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.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21546339
• Report Number: 1017294-2025-00033
• Device Sequence Number: 17889419
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)180328
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2018
• 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