XPS® BLADE
Report
- Report Number
- 1045254-2025-00715
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- December 6, 2024
- Report Date
- March 7, 2025
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- EQJ
- UDI-DI
- 00763000518134
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. H6: INITIALLY SUBMITTED CODE FDC D16 IS NO LONGER APPLICABLE.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:PRODUCT ANALYSIS: 1 OPENED SAMPLE, PART NUMBER 1884006, FROM LOT NUMBER 0226584600. MANUFACTURED ON MAY 15, 2023. PORTIONS OF THE INNER ASSEMBLY WERE NOT RETURNED. THE DEVICE WAS NOT RETURNED WITH THE PACKAGING CARTON, ONLY THE POUCH, AND WAS RETURNED IN A SEALABLE (NON-PACKAGING) POUCH. VISUALLY, PROXIMAL PORTIONS OF THE INNER ASSEMBLY, INCLUDING THE INNER SHAFT AND INNER HUB, WERE BROKEN OFF FROM THE REST OF THE ASSEMBLY AND NOT RETURNED. THERE WAS NO DAMAGE TO THE DISTAL TIP. FUNCTIONALLY, THE DEVICE FAILED DUE TO THE DAMAGED CONDITION UPON RETURN AND THE INABILITY TO LOAD THE DEVICE INTO A HANDPIECE. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL CONSTRUCTION OF THE DEVICE, AND THE ENTIRE SPIRAL WRAP WAS OVEREXPANDED, AND NO PORTION OF THE INNER SHAFT WAS CONNECTED TO THE SPIRAL WRAP NOR RETURNED. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED ONE SIMILAR COMPLAINT ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT DUE TO THE DAMAGED CONDITION OF THE DEVICE UPON RETURN. 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.
ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN DEVICE.
IT WAS REPORTED THAT PRIOR TO PROCEDURE, THERE WAS A PROBLEM WITH THE CONNECTION BETWEEN THE HANDPIECE AND THE TAIL END OF THE BLADE. THERE WAS NO PATIENT INVOLVEMENT. THE BLADE WAS RETURNED TO THE ANALYSIS TEAM IN THE BROKEN CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2480666 | XPS® BLADE | BUR, EAR, NOSE AND THROAT | EQJ | MEDTRONIC XOMED INC. | 1884006 | 0226584600 | 00763000518134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |