MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-04-18 for BUR GUARD, MEDIUM 1375-012 00137501200 manufactured by Conmed Corporation.
[142382705]
This complaint was confirmed. The returned used device, item 00137501200, was inspected per the service and repair procedure and found inner race bearing out of position due to broken bearing. As a result, the bur could not be inserted into the bur guard. Condition of the returned device prevents further testing; however, this type of failure would potentially cause the temperature to increase greatly. 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. A two-year lot history review shows this is the only complaint for this device and lot number combination and failure mode. A two-year review of complaint history revealed there has been a total of 34 complaints, regarding (b)(4) 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). 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 that overheating might occur if bearings are worn or are not kept clean. If overheating occurs, discontinue use and return for service. Before each use, be sure that burs are completely seated and locked in the instrument. If the instrument is activated without the bur completely seated and locked, the bur may be thrown from the instrument with great force. Also, unless the bur is completely locked into place, severe overheating may occur. A determination for further investigation has been initiated. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[142382706]
On behalf of the customer the conmed representative reported issues with the hall oralmax elite high speed drill, item # pro7000de, serial (b)(4) and the bur guard, medium, item # 00137501200, lot# 983015 that occurred during a molar extraction on (b)(6) 2019. It was reported that "during molar extraction on (b)(6) 2019, the unit became very hot and burned a patient's lip. Patient lip blistered. " additional information obtained indicates that the drill & bur guard had been in use for 15-20 minutes. The doctor sectioned and removed tooth #17 with no drill issues and was starting the removal of #32 when the issue occurred. The doctor was sectioning tooth #32 to remove when the drill overheated causing an abrasion to patient's lower right lip adjacent to premolar area. A 5mm diameter blister was noted. No suture was needed, there was no additional medical intervention and the patient's lip / burn was treated with a thin layer of vaseline. The patient is reported to be well at this time and has not returned for treatment. The procedure was successfully completed using another hall drill with no reported delay. The bur guard, medium, item # 00137501200 lot#983015 will be reported on as basis of patient injury (lip burn). The hall oralmax elite high speed drill item # pro7000de is being listed as a concomitant device as the drill itself cannot cause the burn as reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2019-00047 |
| MDR Report Key | 8527700 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2019-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734908 |
| Manufacturer Phone | 7273995557 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337734908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUR GUARD, MEDIUM |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED |
| Product Code | GET |
| Date Received | 2019-04-18 |
| Returned To Mfg | 2019-04-15 |
| Model Number | 1375-012 |
| Catalog Number | 00137501200 |
| Lot Number | 983015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 337734908 US 337734908 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-18 |