MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-28 for ULTRA DRIVE 7MM DISK DRILL N/A 423871 manufactured by Biomet.
[2310726]
During a right hip revision procedure utilizing an ultra-drive tool, the drill tip fractured off in the patient's femoral canal. The tip could not be retrieved and remains in the patient. As a result, a delay of greater than 30 minutes in the procedure was experienced.
Patient Sequence No: 1, Text Type: D, B5
[9496159]
The user facility was notified of the event on (b)(4), 2011. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. Review of device history records show that lot released with no recorded anomaly or deviation. Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly. There are warnings in the package insert that state that this type of event can occur. Package insert 01-50-1112 states: the patient is to be warned that ultra drive tool tips can break or otherwise fail during surgery, and that fragments of broken tool tips can remain at the surgical site after surgery. In addition, intraoperative fracture or breakage of instruments has been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2011-01054 |
| MDR Report Key | 2350039 |
| Report Source | 07 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2011-11-04 |
| Device Manufacturer Date | 2011-03-29 |
| Date Added to Maude | 2011-11-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CRAIG BUCHMAN |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5743721132 |
| Manufacturer G1 | BIOMET |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA DRIVE 7MM DISK DRILL |
| Generic Name | ULTRA-DRIVE TOOL, 7.0 MM DISK DRILL |
| Product Code | JXE |
| Date Received | 2011-11-28 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 477460 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2011-11-28 |