MAUDE Adverse Event Report: CONMED LARGO HALL ORALMAX ELITE HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7000DE

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 341677750
• Report Number: 1017294-2024-00044
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 10845854040904
• UDI-Public: (01)10845854040904(11)191008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: PRO7000DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic