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

Catalog Number	PRO7000SE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the pro7000se, hall micropower+ high speed drill was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the handle is hot and won't work.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer, that the pro7000se, hall micropower+ high speed drill was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the handle is hot and won't work.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 no prior data was found.A two-year review of complaint history revealed there has been a total of 63 complaints, regarding 63 devices, for this device family and failure mode.During this same time frame 3,015 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 0.02.Per the instructions for use, the user is advised to operate the handpiece for one minute according to the operating instructions.Monitor the handpiece for any of the following: excessive noise, excessive vibration, the handpiece or attachment are hot to the touch during the test procedure or during surgical use, and the handpiece does not operate up to its maximum preset speed.Verify the maximum preset operating speed by fully depressing the activation lever or appropriate footswitch pedal and verifying that the maximum speed is displayed on the controller.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HALL MICROPOWER+ 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19270714
• Report Number: 1017294-2024-00050
• Device Sequence Number: 7430031
• Product Code: HAB
• UDI-Device Identifier: 10845854040911
• UDI-Public: (01)10845854040911(11)220523
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: PRO7000SE
• Device Lot Number: 20220074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic