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 2016-02-17 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Biomet Orthopedics.
[38383754]
Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[38383755]
It was reported that patient underwent an elbow arthroplasty on an unknown date with competitor product. Subsequently, patient was revised on (b)(6) 2016 due to unknown reasons. During the procedure, the ultra drive device did not function properly. When the foot pedal was activated, the power display changed into the red area, and the device is blocked. The issue resulted in a delay greater than 30 minutes. A drill was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[40763243]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-00537 |
| MDR Report Key | 5442173 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-17 |
| Date of Report | 2016-02-22 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-02-22 |
| Device Manufacturer Date | 2013-09-25 |
| Date Added to Maude | 2016-02-17 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. 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 III CONSOLE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2016-02-17 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | 25408 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-02-17 |