MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-12 for ULTRA - DRIVE DISK DRILL 423872 manufactured by Biomet, Inc..
[596996]
It was reported that during complex left revision total hip arthroplasty, the tip section of the disk drill fractured. Attempts to remove the fragment were unsuccessful; tip section remains implanted in the patient's femoral canal.
Patient Sequence No: 1, Text Type: D, B5
[7986820]
Current information is insufficient to permit a conclusion as to the cause of the event. No further complications have been reported. Review of device history records show the lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2007-00011 |
| MDR Report Key | 806718 |
| Report Source | 00 |
| Date Received | 2007-01-12 |
| Date of Report | 2006-12-18 |
| Date of Event | 2006-11-22 |
| Date Facility Aware | 2006-11-22 |
| Report Date | 2007-01-12 |
| Date Mfgr Received | 2006-12-18 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-01-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARY HARDESTY, SPEC. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET, INC. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA - DRIVE DISK DRILL |
| Generic Name | JDX |
| Product Code | LZV |
| Date Received | 2007-01-12 |
| Model Number | NA |
| Catalog Number | 423872 |
| Lot Number | 423872 |
| ID Number | NA |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 794227 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. 587 WARSAW IN 465810587 US |
| Baseline Brand Name | ULTRA-DRIVE DISK DRILL |
| Baseline Generic Name | CEMENT REMOVAL SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 423872 |
| Baseline ID | NA |
| Baseline Device Family | ULTRA-DRIVE DISK DRILL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900003 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-12 |