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 2016-09-20 for ULTRA DRIVE TOOLS 9.5MM SHORT OSTEOTOME N/A 423880 manufactured by Biomet Sports Medicine.
[55142519]
(b)(4). The product identification necessary to review manufacturing history was not provided. Visual inspection of the returned device found distal end damage and gouges. The distal end is charred, suggesting possible improper techniques and/or a lack of required irrigation during use. These situations may contribute to over-heating and fracture. Fracture surfaces of the osteotome suggest multiple origin fatigue fractures. A conclusive root cause of the event could not be determined with available information. The following could not be completed with the limited information provided. Date of event - ni; no information was provided about the fracture of the osteotome; however, it may have occurred during another event. This event is reported on 1825034-2016-03461. Manufacture date? Ni.
Patient Sequence No: 1, Text Type: N, H10
[55142520]
Osteotome was found to be fractured. It is unknown if the device fractured during a procedure. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-03721 |
| MDR Report Key | 5963431 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-20 |
| Date of Report | 2016-08-23 |
| Date Mfgr Received | 2016-08-23 |
| Date Added to Maude | 2016-09-20 |
| 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 TOOLS 9.5MM SHORT OSTEOTOME |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2016-09-20 |
| Returned To Mfg | 2016-08-23 |
| Model Number | N/A |
| Catalog Number | 423880 |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-20 |