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

Catalog Number	PRO8300SB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the pro8300sb, hall microfree oscillating saw device was used in a foot and ankle procedure on (b)(6) 2024, and they ¿had a recip saw break today during surgery.Patient wasn¿t harmed.¿.Further assessment found that all fragments were retrieved from the surgical site, and the procedure was completed as normal with an alternate device and a delay of ¿3 minutes for a new saw¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro8300sb, hall microfree oscillating saw device was used in a foot and ankle procedure on (b)(6) 2024, and they ¿had a recip saw break today during surgery.Patient wasn¿t harmed.¿.Further assessment found that all fragments were retrieved from the surgical site, and the procedure was completed as normal with an alternate device and a delay of ¿3 minutes for a new saw¿.There was no injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the device found saw head ¿ broken yoke.Preventative maintenance is overdue.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be lack of preventative and / or exceeded use.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 two reports, regarding two devices, for this device family and failure mode.During this same time frame 1,383 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 0.001.Per the instructions for use, the user is advised the following: the hall® microfree¿ battery handpieces (pro8000sb, pro8100sb, pro8200sb, pro8250sb, pro8300sb, pro8400sb, pro8600sb) and attachments shall be returned every 12 months for servicing.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: 20879425
• Report Number: 1017294-2024-00144
• Device Sequence Number: 7851021
• Product Code: HAB
• UDI-Device Identifier: 10653405005742
• UDI-Public: (01)10653405005742(11)210412
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: PRO8300SB
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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