MAUDE Adverse Event Report: CONMED LARGO CONMED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	PRO6240
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/07/2024
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.H3 other text : device bot yet received.
Event or Problem Description
The customer reported that the pro6240, 1.8-4mm pin driver, device was being used during an unknown procedure on 07may24 when it was reported ¿the patient's skin has been burned.¿.Further assessment questioning found that the patient did receive a small burn, but the degree is unknown.They put on a bandage, & the surgeon didn¿t receive any complaints from the consignee.The procedure was completed with an unknown alternate device.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d1 brand name was updated from 1.8-4mm pin driver to conmed.Manufacturer narrative: additional problems were found.The bearing is no longer effective as it is corroded.The collet failed as it is broken.The preventative maintenance was overdue and completed on this repair order.The final test was completed and met all specifications.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 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 29,439 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 0.00003.Per the instructions for use, the user is advised that failure to follow the maintenance schedule could result in reduced instrument performance or overheating of the handpiece or attachment.In addition, heavy use of the handpiece exceeding the recommended duty cycle can cause the handpiece or attachment to overheat.Overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece and attachment usage per day will assist with proper performance.Conmed recommends that all powerpro attachments be returned for preventive maintenance every 24 months, except for certain attachments indicated in section 3.0 in the hall powerpro attachment manual, which have a recommended service schedule of every 12 months.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the pro6240, 1.8-4mm pin driver, device was being used during an unknown procedure on (b)(6) 2024 when it was reported ¿the patient's skin has been burned.¿.Further assessment questioning found that the patient did receive a small burn, but the degree is unknown.They put on a bandage, & the surgeon didn¿t receive any complaints from the consignee.The procedure was completed with an unknown alternate device.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 19446245
• Report Number: 1017294-2024-00064
• Device Sequence Number: 3213630
• Product Code: HWE
• UDI-Device Identifier: 10845854018934
• UDI-Public: (01)10845854018934(11)201208
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: PRO6240
• Device Lot Number: LAA14827
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic