MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-18 for 5MM REVERSE CURETTE N/A 423859 manufactured by Biomet Orthopedics.
[4536825]
It was reported patient underwent a knee arthroplasty on an unknown date with competitor product. Subsequently, patient underwent a revision procedure on (b)(6), 2014 due to unknown reasons. During the procedure, the ultradrive device displayed the heat warning indicator and sound. Osteotomes were utilized to complete the procedure. A 30 minute delay occurred.
Patient Sequence No: 1, Text Type: D, B5
[12131444]
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 or deviation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-06203 |
| MDR Report Key | 3943801 |
| Report Source | 07 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-06-19 |
| Device Manufacturer Date | 2010-11-05 |
| Date Added to Maude | 2014-07-18 |
| 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. 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 | 5MM REVERSE CURETTE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2014-07-18 |
| Model Number | N/A |
| Catalog Number | 423859 |
| Lot Number | 335080 |
| 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 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 | 2014-07-18 |