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

Catalog Number PRO9300B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 330283186
• Report Number: 1017294-2023-00116
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 40845854050799
• UDI-Public: (01)40845854050799(11)210405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic