MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-09-27 for ULTRA DRIVE 9.5MM DISK DRILL N/A 423872 manufactured by Biomet Orthopedics.
[2888491]
It was reported that patient underwent procedure on (b)(6) 2012. During procedure surgeon attempted to debulke the femur canal with the reverse currette four times when tip fractured. Surgeon then attempted three times with a 9. 5 disk drill before the tip fractured again. Both tips remain in patient.
Patient Sequence No: 1, Text Type: D, B5
[10141266]
Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. 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. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-01755 / 01756).
Patient Sequence No: 1, Text Type: N, H10
[10268852]
Examination of returned device found fracture due to bending overload. There are no visible defects that appear to be caused by biomet. User error is suspected. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-01755-1 / 01756-1).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-01756 |
| MDR Report Key | 2763326 |
| Report Source | 01,08 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-08-29 |
| Date of Event | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Device Manufacturer Date | 2011-09-23 |
| Date Added to Maude | 2012-09-27 |
| 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 9.5MM DISK DRILL |
| Generic Name | DEVICE |
| Product Code | JXE |
| Date Received | 2012-09-27 |
| Returned To Mfg | 2012-09-06 |
| Model Number | N/A |
| Catalog Number | 423872 |
| Lot Number | 978840 |
| 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 | 2012-09-27 |