XPS® BUR
Report
- Report Number
- 9612501-2024-02217
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- August 10, 2024
- Report Date
- April 21, 2025
- Manufacturer
- MEDTRONIC DOMINICANA
- Product Code
- EQJ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H3: PRODUCT ANALYSIS FURTHER FOUND, AFTER FOLLOWING THE STEPS IN THE IFU FOR LOADING THE BUR INTO THE HANDPIECE, THE BUR WAS SECURELY LOADED INTO THE HANDPIECE AND NO WOBBLING WAS OBSERVED WHILE RUNNING UP TO 12 ,000RPM. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: PREVIOUSLY APPLIED CODES FDR C070605 AND IMG G04112 ARE NO LONGER APPLICABLE. IMG G04041 IS APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H6: PREVIOUS ANALYSIS FINDING "FOR FURTHER ANALYSIS, THE OUTSIDE DIAMETER OF THE SHANK WAS 0.059 INCHES" IS NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H3: VISUALLY, THE PACKAGING POUCH WAS OPENED ON 3 OF THE 4 SIDES AND THERE WAS NO DAMAGE TO THE PACKAGING TRAY. ADDITIONALLY, THERE WAS NO DAMAGE TO THE DISTAL DIAMOND GRIT TIP AND THE DEVICE WAS NOT BROKEN. UNDER MAGNIFICATION, THERE WERE STRIATIONS IN THE SHANK UPON RETURN. THE OVERALL LENGTH OF THE DEVICE SHALL BE 3.850 +0.015/-0.010 INCHES, AND THE ACTUAL MEASUREMENT WAS 3.85 INCHES WHICH WAS IN SPECIFICATION. THE OUTSIDE DIAMETER OF THE SLEEVE SHALL BE 0.062 ± 0.001 INCHES, AND THE ACTUAL MEASUREMENT WAS 0.062 INCHES WHICH WAS IN SPECIFICATION. FOR FURTHER ANALYSIS, THE OUTSIDE DIAMETER OF THE SHANK WAS 0.059 INCHES. FUNCTIONALLY, THE BUR SECURELY FIT INTO A HANDPIECE, BUT WHILE RUNNING IN FORWARD MODE EXCESSIVE WOBBLING AND GRINDING WERE OBSERVED. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED NO OTHER COMPLAINTS ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: CODES ARE UPDATED. PREVIOUSLY APPLIED FDM B17, FDR C20, FDC D16 AND IMG G04041 CODES NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H6: FURTHER ANALYSIS STATED THAT THE OUTSIDE DIAMETER OF THE SHANK WAS 0.059 INCHES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT PRE-OP, THE SKEETER BURS WERE WOBBLING AFTER INSERTION. ALL THE FOUR BURS WERE TESTED WITH SAME HANDPIECE. THE PROCEDURE WAS COMPLETED USING OTHER BURS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887103 | XPS® BUR | BUR, EAR, NOSE AND THROAT | EQJ | MEDTRONIC DOMINICANA | 3155646 | 0226608117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |