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

Catalog Number	PRO9200B
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
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.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro9200b, hall titan dual trigger battery handpiece device was being used during a reverse total shoulder arthroplasty procedure on (b)(6) 2024, and ¿titan drill spinning on own¿.Further assessment found that the surgeon "stopped drilling and then the drill started spinning on its own", and "the battery that was in use had a partially eroded posisitve terminal.It was also taken out of service".Additionally, the sales representative stated "no reason to believe it was the battery or a manufacturing issue, they was old and when i looked at it it had allot of corrosion from poor upkeep".The procedure was completed with an unnamed alternate device and a delay of 5 minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The device l3000lg, hall large lithium battery was used during this reported event and will be listed as a concomitant device; there is no allegation against it.
Additional Manufacturer Narrative
The reported event of ¿stopped drilling then started spinning on its own¿ is not confirmed.Additionally, evaluation found the radial lip seal worn/failed.Parts were replaced and the device repaired; the device was final tested and met all specifications.A device history record review was not conducted as the device has been in the field for more than 12 months.The service history was reviewed, and no prior data was found.(b)(4).Per the instructions for use, the user is advised to perform the required preoperative functional tests for the equipment and accessories prior to each use.After each use, thoroughly clean and inspect the handpiece and accessories.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro9200b, hall titan dual trigger battery handpiece device was being used during a reverse total shoulder arthroplasty procedure on (b)(6) 2024, and ¿titan drill spinning on own¿.Further assessment found that the surgeon "stopped drilling and then the drill started spinning on its own", and "the battery that was in use had a partially eroded posisitve terminal.It was also taken out of service".Additionally, the sales representative stated "no reason to believe it was the battery or a manufacturing issue, they was old and when i looked at it it had allot of corrosion from poor upkeep".The procedure was completed with an unnamed alternate device and a delay of 5 minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The device l3000lg, hall large lithium battery was used during this reported event and will be listed as a concomitant device; there is no allegation against it.

• Brand Name: HALL TITAN DUAL TRIGGER 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19060816
• Report Number: 1017294-2024-00037
• Device Sequence Number: 12431604
• Product Code: HAB
• UDI-Device Identifier: 40845854050836
• UDI-Public: (01)40845854050836(11)230112
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/19/2024

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: PRO9200B
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: L3000LG, HALL LARGE LITHIUM BATTERY; L3000LG, HALL LARGE LITHIUM BATTERY
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic