MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-15 for TITANEX DRIVER ZT702-06-09 manufactured by Vilex, Inc..
[26191481]
On 06/08/2015, vilex received information regarding a driver, zt702-06-09, where the tip had chipped while loading into the handle. On 07/27/2015, vilex received driver. Vilex's quality department evaluated the driver. The only damage was to the tip of the driver. Vilex believes that the driver was either loaded into the handle backwards or was dropped. Vilex made several attempts to contact the account manager to clarify what occurred during surgery. No responses were ever received. A review of vilex's complaints revealed that no complaints have been filed against this product. Should more information become available, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[26191482]
Tip of instrument (driver) broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2015-00007 |
| MDR Report Key | 5084100 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-06-18 |
| Date Mfgr Received | 2015-06-18 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-09-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal | 37110 |
| Manufacturer Phone | 9314747550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TITANEX DRIVER |
| Generic Name | TITANEX 2.0 DRIVER |
| Product Code | DWI |
| Date Received | 2015-09-15 |
| Returned To Mfg | 2015-07-29 |
| Model Number | ZT702-06-09 |
| Lot Number | 6627 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VILEX, INC. |
| Manufacturer Address | MCMINNVILLE TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-15 |