MAUDE Adverse Event Report: CONMED LARGO HALL® TITAN¿ PRIMECUT+¿; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO9350B
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 for trends through the complaint system to assure patient safety.H3 other text: device not yet received.
Event or Problem Description
The customer reported that the device, (b)(4), hall titan primecut+ oscillating saw battery handpiece was being used and the ¿housing seems loose and slows down when blade hits bone¿.There was no report of impact or injury for the patient or the user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Collette is loose.Additional problems found.Saw head- press ring loose.Preventive maintenance overdue.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be overdue preventative maintenance.The service history was reviewed and no relationship to this complaint was found.A device history record review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 19 reports, regarding 19 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: it is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward the user with safer, less problematic product performance over time.This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment.Failure to follow the 12-month service interval could result in reduced instrument performance or overheating of the handpiece.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, pro9350b, hall titan primecut+ oscillating saw battery handpiece was being used and the ¿housing seems loose and slows down when blade hits bone¿.There was no report of impact or injury for the patient or the user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL® TITAN¿ PRIMECUT+¿
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20745182
• Report Number: 1017294-2024-00136
• Device Sequence Number: 15615635
• Product Code: HAB
• UDI-Device Identifier: 40845854050805
• UDI-Public: (01)40845854050805(11)221105
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: PRO9350B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• 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