MAUDE Adverse Event Report: CONMED LARGO HALL TITAN OSCILLATING SAW BATTERY HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO9300B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
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 sales representative reported on behalf of the customer, that the pro9300b, hall titan oscillating saw battery handpiece was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿saw came apart.¿there was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The preventative maintenance (pm) was overdue.Housing broke off where head meets housing.The housing was replaced, and the trigger assembly rebuilt.A preventative maintenance (pm) service was completed.Repair is completed.Leak and final tests passed.A root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be the device was not serviced as recommended per instructional manual.The service history was reviewed, and no prior data was found.A device history record review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised that regular and proper maintenance of your equipment is the best way to protect your investment.It is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time.The hall titan handpieces shall be returned every 12 months for servicing.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Update: further assessment information found that the device was being used during a total knee replacement procedure.The device did fragment and was removed from the surgical site by the pa and the procedure was completed.The sales representative reported on behalf of the customer, that the pro9300b, hall titan oscillating saw battery handpiece was being used during an unknown procedure on (b)(6) 2023 when it was reported "saw came apart." there was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL TITAN OSCILLATING SAW BATTERY HANDPIECE
• 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: 18310768
• Report Number: 1017294-2023-00116
• Device Sequence Number: 14981143
• Product Code: HAB
• UDI-Device Identifier: 40845854050799
• UDI-Public: (01)40845854050799(11)210405
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: PRO9300B
• Device Lot Number: 20210210
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic