MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for XPS? BUR 3155648 manufactured by Medtronic Xomed Inc..
[183000686]
The product analysis result indicates that the cutting tip was detached from the distal end which would have resulted in the reported event. The portion that became detached was not returned but would have measured approximately 1/2?. The teflon bushings showed deformation and detached; and the shaft showed wear which indicates use. The evidence and biological contaminants are not consistent with the issue occurring before use. The customer insinuated that the tips were damaged upon opening the package however this would have been immediately noticeable to manufacture? If? The issue were present at that time. The manufacturing instructions require a 100% visual and pull test during production to ensure the tip is securely fastened to the bur assembly. A review of the global complaint data showed no other complaints for either lot identified on this event and no complaints for this part number in the last 12 months; in contrast, this facility reported an issue with both on the same day with the same failure mechanism. The information most likely indicates the damage occurred during use. In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage). The most likely underlying cause is consistent with, misuse / use error. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183000687]
It was reported that pre operatively the devices were broken upon opening it from the sealed pack. Both tips were damaged. There was no patient involvement. Upon follow up it was confirmed that it was the distal tip of the device that was broken, there was no fragment detached. A new bur was used and completed the procedure with around 10minutes of delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00121 |
| MDR Report Key | 9770476 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2020-02-28 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? BUR |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 3155648 |
| Catalog Number | 3155648 |
| Lot Number | 0215716710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |