MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-02 for ULTRA DRIVE 7MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[2733761]
It was reported that patient underwent femoral revision on unknown date. During the procedure, the disk drill fractured. The surgery was completed using another drill, with no reported patient injury, or delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10091592]
The user facility is outside of the united states. No medwatch report was received. The product lot identification necessary to review manufacturing history was not provided. 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 precautions, it states, "intraoperative fracture or breakage of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture".
Patient Sequence No: 1, Text Type: N, H10
[10148455]
Review of returned device found that post-fracture damage had obfuscated most artifacts that would suggest a fracture mode and origin. Remaining fracture artifacts suggest the fracture may have been caused by a bending overload. The measurable parts of the returned device were found to meet specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-01199 |
| MDR Report Key | 2678779 |
| Report Source | 01,07 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-07-11 |
| Date Mfgr Received | 2012-07-11 |
| Date Added to Maude | 2012-11-26 |
| 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 | 5743711021 |
| 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 | 2012-08-02 |
| Returned To Mfg | 2012-08-07 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | UNK |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2012-08-02 |