MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-27 for 4 MM HIGH SPEED TAPERED DIAMOND BURR 1883672HS manufactured by Medtronic Xomed Inc..
[24213056]
Patient Sequence No: 1, Text Type: N, H10
[24213057]
Endonasal sinus surgery was in progress when the high speed tapered diamond, 4mm 70 degree, burr's tip (ref# (b)(4)/lot#0209598413) was noted to be missing. No patient/staff harm. Additional burrs obtained for procedure to continue. Two more endonasal drill attachments from the same manufacturer/company broke during the case: first, ref#(b)(4)/ lot#0209504794 - high speed round diamond burr, 5mm 15 degree, burr's 䓠neck broke and the tip popped out while in use. Second, ref#(b)(4)/ lot#0209237919 - high speed tapered diamond burr 4mm 70 degree, burr broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5034322 |
| MDR Report Key | 5034322 |
| Date Received | 2015-08-27 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-07-23 |
| Report Date | 2015-08-14 |
| Date Reported to FDA | 2015-08-14 |
| Date Reported to Mfgr | 2015-08-14 |
| Date Added to Maude | 2015-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4 MM HIGH SPEED TAPERED DIAMOND BURR |
| Generic Name | BURR |
| Product Code | HTT |
| Date Received | 2015-08-27 |
| Catalog Number | 1883672HS |
| Lot Number | 0209598413 |
| ID Number | 4MM 70 DEGREE |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR., NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-27 |