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)
Type of Reportable Event	Malfunction
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 device was ¿getting hot need loaner¿.The report was received through the service and repair department, with no further information about the event.Further assessment found that the customer was unaware of the device being involved in any event involving a patient, or causing any injury, whether to a patient or user.She thought that one of the doctors was probably using the device and ¿felt it getting warm in his hand¿.No further information was available.There was no report of injury, medical/surgical intervention or extended hospitalization required for any patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the device found the unit failed heat test, abnormal noise, cast stator ¿ visual internal damage, and cast stator ¿ ground bond.Preventative maintenance is not overdue.Repair/evaluation completed.Final test completed and met all specifications.Root cause cannot be determined, however, based upon the risk document; a possible cause of this event could be duty cycle exceeded.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 repairs to this complaint.A two-year review of complaint history revealed there has been a total of 74 reports, regarding 78 devices, for this device family and failure mode.During this same time frame 2,619 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 0.03.Per the instructions for use, the user is advised the following: 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.
Event or Problem Description
A customer reported that the pro7000de, hall oralmax elite high speed drill device was ¿getting hot need loaner¿.The report was received through the service and repair department, with no further information about the event.Further assessment found that the customer was unaware of the device being involved in any event involving a patient, or causing any injury, whether to a patient or user.She thought that one of the doctors was probably using the device and ¿felt it getting warm in his hand¿.No further information was available.There was no report of injury, medical/surgical intervention or extended hospitalization required for any patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 20923956
• Report Number: 1017294-2024-00150
• Device Sequence Number: 8314474
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)180614
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 11/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2018
• 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