MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-04-22 for RAYHACK ANGLED DRILL GUIDE 4010-0206 manufactured by Wright Medical Technology, Inc..
[1491883]
Allegedly angled guide wouldn't fit into the horizontal compression block.
Patient Sequence No: 1, Text Type: D, B5
[8645603]
This is a reportable malfunction. Investigation is not complete. Trends will be evaluated. No serious injury occurred; therefore, no patient information is applicable. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2010-00112 |
| MDR Report Key | 1674326 |
| Report Source | 05,07 |
| Date Received | 2010-04-22 |
| Date of Report | 2010-04-08 |
| Date of Event | 2010-03-05 |
| Date Facility Aware | 2010-03-05 |
| Date Mfgr Received | 2010-04-08 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2010-09-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 040810-002R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAYHACK ANGLED DRILL GUIDE |
| Generic Name | SMALL JOINT INSTRUMENT |
| Product Code | LXI |
| Date Received | 2010-04-22 |
| Returned To Mfg | 2010-03-17 |
| Model Number | NA |
| Catalog Number | 4010-0206 |
| Lot Number | 049581514 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-22 |