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

Catalog Number	PRO9350B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the pro9350b hall titan primecut+ oscillating saw battery handpiece was being used on an unknown date during a knee replacement operation and the ¿saw stops when there is resistance¿.There was no impact or injury to the patient.The procedure was completed with a delay of a ¿couple of minutes, new saw was taken¿.The patient¿s condition was reported as ¿recovering from surgery ¿normal status¿.¿ this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found that the blade contacts are worn/damaged, and the oscillator head assembly is leaking.The unit was repaired, evaluation completed and final tested.The unit met all specifications.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be overdue preventative maintenance.The preventive maintenance was completed as part of this repair order.The service history was reviewed and no relationship to this complaint was found.A device history record (dhr) 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 11 reports, regarding 11 devices, for this device family and failure mode.During this same time frame 9,850 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: prior to each use, ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.The hall® titan¿ handpieces shall be returned every 12 months for servicing.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the pro9350b hall titan primecut+ oscillating saw battery handpiece was being used on an unknown date during a knee replacement operation and the ¿saw stops when there is resistance¿.There was no impact or injury to the patient.The procedure was completed with a delay of a ¿couple of minutes, new saw was taken¿.The patient¿s condition was reported as ¿recovering from surgery ¿normal status¿.¿.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: 20989100
• Report Number: 1017294-2024-00163
• Device Sequence Number: 15603300
• Product Code: HAB
• UDI-Device Identifier: 40845854050805
• UDI-Public: (01)40845854050805(11)230707(10)20230424
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic