MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-05-17 for 2.0MM THREADED DRILL GUIDE 323.061 manufactured by Synthes (usa).
[15557904]
Drill guide color indicator ring is purple instead of orange.
Patient Sequence No: 1, Text Type: D, B5
[15919148]
Subject device is an instrument and is not implanted. Incorrect color coding was discovered during inventory stocking and was never used in surgery. Review of device history records shows that the part was mfg according to an incorrect design index. Investigations have shown that the complained threaded drill guides are marked purple instead of orange.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2007-00033 |
| MDR Report Key | 851720 |
| Report Source | 05,07 |
| Date Received | 2007-05-17 |
| Date of Report | 2007-01-03 |
| Date of Event | 2007-01-02 |
| Date Mfgr Received | 2007-01-02 |
| Device Manufacturer Date | 2006-10-07 |
| Date Added to Maude | 2007-05-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES (USA) |
| Manufacturer Street | 1051 MONUMENT AVE. |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM THREADED DRILL GUIDE |
| Generic Name | THREADED DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2007-05-17 |
| Returned To Mfg | 2007-02-02 |
| Model Number | NA |
| Catalog Number | 323.061 |
| Lot Number | 1531434 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 839084 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA 19380 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-17 |