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	01/16/2025
Type of Reportable Event	Malfunction
Additional 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the pro7000de, hall oralmax elite high speed drill, device was being used on a (b)(6) 2025 during an unknown procedure when it was reported ¿gets hot.".There was no report of injury, medical intervention, extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the pro7000de, hall oralmax elite high speed drill, device was being used on a 16jan25 during an unknown procedure when it was reported ¿gets hot.".There was no report of injury, medical intervention, extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event ¿gets hot¿ was confirmed.There was rotor failure (bearing) and the device failed the heat test.The bearings of the collet failed and the lever was damaged.Preventative maintenance was not overdue.The repair was completed and the final test met all specifications.Root cause cannot be determined, however, based upon evaluation of the device and the ifu; a possible cause of this event could be rotor and collet failure.The service history was reviewed and found similar repairs to this complaint.A device history record review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 59 complaints, regarding 59 devices, for this device family and failure mode.During this same time frame 2,303 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 to monitor the handpiece for any of the following: excessive noise, excessive vibration, or if the handpiece or attachment are hot to the touch during the test procedure or during surgical use.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21321003
• Report Number: 1017294-2025-00017
• Device Sequence Number: 18316920
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)191002
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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
• Device Lot Number: 20190220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic