MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-11 for ACCUTRAK - MINI * ATM080 manufactured by Midwestern Medical Co..
[246126]
Ankle arthroscopy procedure - used mini accutrak screw to fixate a fracture. When tightening the screw into place, the tip of screwdriver broke off. Broken piece removed from pt's ankle. Used a second screwdriver to finish tightening the screw into place and the same thing happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022147 |
| MDR Report Key | 337333 |
| Date Received | 2001-06-11 |
| Date of Report | 2001-05-14 |
| Date of Event | 2001-05-14 |
| Date Added to Maude | 2001-06-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUTRAK - MINI |
| Generic Name | SCREW DRIVER |
| Product Code | HXY |
| Date Received | 2001-06-11 |
| Model Number | * |
| Catalog Number | ATM080 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 326637 |
| Manufacturer | MIDWESTERN MEDICAL CO. |
| Manufacturer Address | 1239 N HIGH ST COLUMBUS OH 43201 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-11 |