MAUDE Adverse Event Report: CONMED LARGO HALL 50 1-TRIGGER MODULAR HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7100B

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/07/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the pro7100b, hall 50 1-trigger modular handpiece, was used during an unknown type of procedure on (b)(6) 2022 when it was reported, ¿device got very hot, bearings burnt patient.¿ the procedure was completed as planned with an alternate device causing a 5-minute delay.There was no report of medical intervention or hospitalization for the patient.Further assessment information has been requested; however, no further information has been made available to date.This report is being raised on the basis of injury due to unknown degree of burn to patient.

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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the pro7100b, hall 50 1-trigger modular handpiece, was used during an unknown type of procedure on (b)(6) 2022 when it was reported, ¿device got very hot, bearings burnt patient.¿ the procedure was completed as planned with an alternate device causing a 5-minute delay.There was no report of medical intervention or hospitalization for the patient.Further assessment information has been requested; however, no further information has been made available to date.This report is being raised on the basis of injury due to unknown degree of burn to patient.

Manufacturer Narrative

The device was overdue for a pm.Additionally, the device was found to suffer from gearbox failure which required preventive maintenance and seal failure.The device was repaired, tested, and met all specifications.The manufacturing documents from the device history record have not been reviewed because the device has been in the field for longer than one year.The service history was reviewed and found similar lack of preventive maintenance to this device.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 13 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 that failure to follow the specified service interval could result in reduced instrument performance or overheating of the handpiece.Overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.The hall 50 handpieces shall be returned every 12 months for servicing.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL 50 1-TRIGGER MODULAR 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13955612
• MDR Text Key: 288287482
• Report Number: 1017294-2022-00040
• Device Sequence Number: 1
• Product Code: HAB
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO7100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic