MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-15 for ACUMED * manufactured by Acumed, Inc..
[230161]
Add'l info rec'd from mfr 4/5/02: the mini-acutrak cannulated hex driver has undergone three significant design modifications. The first design change (6/25/97) involved the addition of a groove near the tip of the driver. This groove provides a controlled break-off point enabling the surgeon to easily remove the broken tip should the surgeon apply excessive torque to the driver. The second design change (5/10/01) involved a change in heat treating the part to improve torque resistance. The third design change (6/12/01) involved the increasing the cannulation of the driver to accommodate a wider diameter k-wire. Test data on file at acumed concludes that even with the increase in cannulation diameter, the drivers still possess a torque value significantly above (6. 19 in/lbs) which complies with iso 8319-1. To address the question of life expectancy and anticipated failure rate, please refer to the package insert for reusable instruments. Within the info for use section, mfr makes the statement that instruments are reusable and have a limited life span. Insert further requires the user to inspect the instruments for sharpness, wear, damage, proper cleaning, corrosion, and integrity of connecting mechanisms prior to and after to every use. Please note that mfr emphasizes the following: "particular attention should be paid to hex drivers, drill bits, and any instruments used for cutting or implant insertion. "
Patient Sequence No: 1, Text Type: D, B5
[16029202]
Acumed mini acutrak cannulated hex driver tip broke off while inserting screw into bone. Tip found and removed with use of x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024099 |
| MDR Report Key | 377482 |
| Date Received | 2002-02-15 |
| Date of Report | 2002-01-22 |
| Date of Event | 2002-01-22 |
| Date Added to Maude | 2002-02-22 |
| 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 |
| 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 | ACUMED |
| Generic Name | MINI ACUTRAK CANNULATED HEX DRIVER |
| Product Code | HXY |
| Date Received | 2002-02-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 366545 |
| Manufacturer | ACUMED, INC. |
| Manufacturer Address | * BEAVERTON OR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-02-15 |