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

Catalog Number	PRO7000SE
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
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
The sales representative reported on behalf of the customer that the pro7000se, hall micropower+ high speed drill device was being used during a dental procedure on (b)(6) 2025 when it was reported ¿the handpiece (whipped) during use on the patient.Patient bone was inadvertently damaged as a result.I am not sure of any further details; this is the only information i have been given.¿.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to the patient¿s bone being damaged.
Event or Problem Description
Update: further information was provided on june 5, 2025, from the customer and it was confirmed that the altered bone cut did not result in any injury.There was no surgical intervention because of the incident.There was no real surgical delay, we only had to open up another drill.The surgery was completed as planned and the patient recovered well.Dr.Was only concerned about the way the drill behaved and that it altered the cut.This report will be updated from serious injury to malfunction.The sales representative reported on behalf of the customer that the pro7000se, hall micropower+ high speed drill device was being used during a dental procedure on (b)(6) 2025 when it was reported "the handpiece (whipped) during use on the patient.Patient bone was inadvertently damaged as a result.I am not sure of any further details; this is the only information that i have been given." there was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of "whipped during surgery" was unconfirmed.No fault found.The preventative maintenance was overdue.The unit was tested and met all specifications.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 relationship to this complaint was found.(b)(4).Per the instructions for use, the user is advised that the micropower+ handpieces and attachments shall be returned every 12 months for servicing.Regular and proper maintenance of your equipment is the best way to protect your investment.It is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: HALL MICROPOWER+
• 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: 22135780
• Report Number: 1017294-2025-00056
• Device Sequence Number: 8500194
• Product Code: HAB
• UDI-Device Identifier: 10845854040911
• UDI-Public: (01)10845854040911(11)200430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PRO7000SE
• Device Lot Number: 20200111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic