MAUDE Adverse Event Report: CONMED CORPORATION HALL MICROPOWER + HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7000SE

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant devices are as follows: pro7000se sn (b)(4).Pro7000se sn (b)(4).Pro7000se sn (b)(4).Pro7000se sn (b)(4).Pro7000se sn (b)(4).Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received.At time of filing, although expected, the reported device has not been 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.

Event Description

On behalf of the customer in (b)(6), the conmed sales representative reported an issue with six (6) pro7000se, hall micropower + high speed drill.It was noted that "the drills are overheating bur guards and burning patients' lips." additional clarification was obtained that indicated the conmed representative was told by the physician and the staff that the drills were heating up more than normal and had burned a patient's lip.No other information was provided to him.They requested the six (6) drills to be sent in and serviced for preventative precautionary measures.It was clarified that one (1) patient and one (1) device was involved in the reported burning of the lip.The reported date of event is an approximate date reported tot the conmed representative.As the facility did not identify which device was involved with the reported injury, and there was only one (1) reported burn, only one (1) incident/ device will be reported to the fda.The remaining five (5) devices will be listed as concomitant on this fda filing as they are being sent in for precautionary maintenance.This report is being raised as an injury due to the reported lip burn.

Manufacturer Narrative

The reported event of "overheating bur guards burned patient on the lips" is inconclusive.The bur guards were not returned for evaluation and no photographic evidence of the burned lip was provided however, a device that may have been used with the bur guards was returned for evaluation, the pro7000se.It could not be confirmed that this specific device was the one which caused the burn.Evaluation of the returned pro7000se device found the unit overheating due to cast stator and rotor failure and the device failed the heat test but preventative maintenance was not overdue.Parts were replaced, the device was repaired, and the preventative maintenance was performed; the device passed final test and met all specifications.Additionally, assessment of the complaint and evaluation results by r&d indicate that improperly maintained bur guards might cause burns to the patient however none were returned for evaluation.Additionally, motor failure may get the entire hand piece hot however it is believed that it would not get hot enough to burn the patient's lip.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.The service history was reviewed, and no previous service data was found.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 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 0.004.Please note however, because this is a reusable device, the potential number of uses is not considered in this failure rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is also advised to continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.Overheating can occur if guard bearings are worn and not kept clean.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL MICROPOWER + HIGH SPEED DRILL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo, fl
• MDR Report Key: 9716868
• MDR Text Key: 192460975
• Report Number: 1017294-2020-00073
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO7000SE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (5) PRO7000SE.
• Patient Outcome(s): Other