MAUDE Adverse Event Report: CONMED LARGO HALL ORALMAX ELITE HIGH SPEED DRILL; 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	03/29/2024
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 for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
A customer reported that during pre-operative tesing on (b)(6) 2024, the pro7000de, hall oralmax elite high speed drill device ¿gets hot¿.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation found the cast stator won¿t run and the device was unable to be disassembled.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 was reviewed and found similar repairs to this complaint.A two-year review of complaint history revealed there has been a total of 98 reports, regarding 102 devices, for this device family and failure mode.During this same time frame 3,028 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 (ifu), the user is advised to perform the required preoperative functional tests for the equipment and accessories prior to each use.The ifu also advises the user 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A customer reported that during pre-operative tesing on 29mar24, the pro7000de, hall oralmax elite high speed drill device ¿gets hot¿.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL ORALMAX ELITE HIGH SPEED DRILL
• 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: 19166761
• Report Number: 1017294-2024-00044
• Device Sequence Number: 12749866
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)191008
• 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): 05/17/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• 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