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

Catalog Number	PRO8200SB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event 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 data was found.A two-year review of complaint history revealed there has been a total of one report, regarding one device, for this device family and failure mode.During this same time frame 1,290 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 0.0008.Per the instructions for use, the user is advised the following: prior to each use, ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the pro8200sb, hall microfree sagittal saw device was used in an unknown procedure on (b)(6) 2025, and ¿when a sagittal blade ¿ was attached to the microfree sagittal saw to perform bone cutting, the blade easily came off.¿.There was no injury to the patient or user.The procedure was completed without the use of an alternate device and no reported delay.Further assessment found "the blade is not broken, but it has come off the handpiece", fell into the surgical site and was retrieved.There was no report of 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 MICROFREE
• 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: 23525833
• Report Number: 1017294-2025-00113
• Device Sequence Number: 9065636
• Product Code: HAB
• UDI-Device Identifier: 10653405005735
• UDI-Public: (01)10653405005735(11)180626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: PRO8200SB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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