|
|
| Model Number ATM-080, HD0015, 041796AA |
|
Patient Outcome
Hospitalization;
|
|
Event Description
|
Tip of screwdriver broke off in patella during surgery.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | MINI-ACUTRAK |
|---|
| Type of Device | SCREW DRIVER FOR ORTHOPEDIC USE |
|---|
| Baseline Brand Name | MINI-ACUTRAK |
|---|
| Baseline Generic Name | ORTHOPEDIC INSTRUMENT |
|---|
| Baseline Catalogue Number | HD0015 |
|---|
| Other Baseline ID Number | ATM-080 (HANDLE) |
|---|
| Baseline Device Family | ACUTRAK SOLID HEX DRIVERS |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
Yes
|
|---|
| Shelf Life(Months) | NA |
|---|
| Date First Marketed | 05/05/1995 |
|---|
| Manufacturer (Section D) |
|
| Device Event Key | 408104 |
|---|
| MDR Report Key | 419060 |
|---|
| Event Key | 396324 |
|---|
| Report Number | MW1026274 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | HTW |
|---|
| Report Source |
Voluntary
|
|---|
| Report Date |
09/24/2002 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 09/24/2002 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device MODEL Number | ATM-080, HD0015, 041796AA |
|---|
| Device Catalogue Number | 122895AA |
|---|
| Was Device Available For Evaluation? |
Yes
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on January 30, 2009
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