MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2003-05-02 for ULTRA-DRIVE DISK DRILL 423871 manufactured by Arthrotek/biomet.
[266054]
It was reported that during procedure utilizing the ultra-drive cement removal system, the tip of the 9. 5mm disk drill fractured. Surgeon elected not to remove tip. The date of the event was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-2003-00063 |
| MDR Report Key | 457722 |
| Report Source | 01,07 |
| Date Received | 2003-05-02 |
| Date of Report | 2003-04-11 |
| Date Mfgr Received | 2003-04-11 |
| Date Added to Maude | 2003-05-07 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BETH ALBERT, AST. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMED, 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 | CEMENT REMOVAL SYSTEM |
| Product Code | LZV |
| Date Received | 2003-05-02 |
| Model Number | NA |
| Catalog Number | 423871 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 446708 |
| Manufacturer | ARTHROTEK/BIOMET |
| Manufacturer Address | P.O. BOX 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 | 423871 |
| 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 | 2003-05-02 |