MAUDE Adverse Event Report: CONMED LARGO HALL; 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	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Event or Problem Description
Conmed canada reported that the pro7000se, hall micropower+ high speed drill, device was found on 17jun24 when it was reported ¿handpiece noisy and getting hot quick.¿.There was no report of injury, medical 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.
Event or Problem Description
Conmed canada reported that the pro7000se, hall micropower+ high speed drill, device was found on 17jun2024 when it was reported ¿handpiece noisy and getting hot quick.¿.There was no report of injury, medical 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
Correction: d1 brand name was updated from hall micropower+ high speed drill to hall manufacturer narrative: the evaluation found that the collet failed.The collet had debris and corrosion.The rotor was binding.The preventive maintenance was overdue.The repairs and preventive maintenance were completed.The final test was completed and met all specifications.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be worn bearings in the collet and moisture in the handpiece.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 found similar repairs to this complaint.A two-year review of complaint history revealed there has been a total of 89 complaints, regarding 93 devices, for this device family and failure mode.During this same time frame 3,172 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 never clean handpieces with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any products containing sodium hydroxide (such as, instru-klenz or buell cleaner).These products degrade the anodized aluminum coating and may result in reduced handpiece reliability.For aluminum surfaces, a neutral-ph agent should be used.To prevent corrosion, avoid contact with strong alkaline solutions (ph over 10.5) or agents containing iodine or chlorine.Use of a washer/sanitizer will decrease the life expectancy of the handpiece.We will continue to monitor for trends through the complaint system to assure 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: 19690875
• Report Number: 1017294-2024-00082
• Device Sequence Number: 20622093
• Product Code: HAB
• UDI-Device Identifier: 10845854040911
• UDI-Public: (01)10845854040911(11)231121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic