MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for ULTRA-DRIVE 423872 manufactured by Biomet, Inc..
[66586683]
Patient Sequence No: 1, Text Type: N, H10
[66586684]
A biomet ultra drive tool tip (drill) broke while being used on patient in surgery. All the pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6303664 |
| MDR Report Key | 6303664 |
| Date Received | 2017-02-06 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-11-29 |
| Report Date | 2016-12-16 |
| Date Reported to FDA | 2016-12-16 |
| Date Reported to Mfgr | 2016-12-16 |
| Date Added to Maude | 2017-02-06 |
| 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 | ULTRA-DRIVE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2017-02-06 |
| Model Number | 423872 |
| Lot Number | 313970 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |