MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-07-22 for ULTRA DRIVE TOOL 7.0 MM DISK DRILL N/A 423871 manufactured by Biomet Orthopedics.
[16517605]
Evaluation of the returned device found evidence to suggest a fatigue fracture.
Patient Sequence No: 1, Text Type: N, H10
[19571757]
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. Review of device history records show that lot released with no recorded anomaly or deviation. 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. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. " this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2012-01116 / 01117).
Patient Sequence No: 1, Text Type: N, H10
[19688668]
It was reported patient underwent total hip arthroplasty revision of non-biomet products on (b)(6), 2012. During the procedure, the surgeon used the ultra drive tip to remove the bone cements when a shaft fractured. Subsequently, when the surgeon used a second ultra drive tip to remove the first ultra drive tip the second ultra drive tip fractured also the surgeon used an im reamer to remove the second ultra drive tip. The first ultra drive tip remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2012-01116 |
| MDR Report Key | 2664285 |
| Report Source | 01,07 |
| Date Received | 2012-07-22 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-20 |
| Date Mfgr Received | 2012-06-29 |
| Device Manufacturer Date | 2011-08-25 |
| Date Added to Maude | 2012-07-23 |
| 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. ANGELA 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 TOOL 7.0 MM DISK DRILL |
| Generic Name | DEVICE |
| Product Code | JXE |
| Date Received | 2012-07-22 |
| Returned To Mfg | 2012-07-24 |
| Model Number | N/A |
| Catalog Number | 423871 |
| Lot Number | 342780 |
| 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 | 1. Hospitalization; 2. Deathisabilit | 2012-07-22 |