MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-01-03 for ULTRA DRIVE 7MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[15297984]
Review of device history records show that lot released with no recorded anomaly or deviation. Dimensional evaluation found component to be within appropriate design specification.
Patient Sequence No: 1, Text Type: N, H10
[20649291]
It was reported patient underwent a shoulder procedure on (b)(6) 2012, utilizing an ultra drive disc drill. The disc drill fractured during use and was retrieved from the wound. Another ultra drive disc drill was used to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
[20865617]
The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "the surgeon is to be thoroughly familiar with the equipment and the surgical procedure prior to performing surgery. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-00014 |
| MDR Report Key | 2894718 |
| Report Source | 01,07 |
| Date Received | 2013-01-03 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-11-29 |
| Date Mfgr Received | 2012-12-10 |
| Device Manufacturer Date | 2011-10-19 |
| Date Added to Maude | 2013-01-03 |
| 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 | MS. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| 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 | DEVICE |
| Product Code | JXE |
| Date Received | 2013-01-03 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 891890 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-03 |