MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-15 for TORQUE-LIMITING T-HANDLE 7NM 321.133 manufactured by Synthes Monument.
[2898467]
A hospital in (b)(6) reported the torque limiter does not work.
Patient Sequence No: 1, Text Type: D, B5
[10484760]
This device is used for treatment not diagnosis. Investigation is on-going. Subject device has been received and is currently in the evaluation process. No conclusion can be drawn. Manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2012-01370 |
| MDR Report Key | 2874604 |
| Report Source | 01,07 |
| Date Received | 2012-12-15 |
| Date of Report | 2012-11-16 |
| Date Mfgr Received | 2012-11-16 |
| Device Manufacturer Date | 2007-02-12 |
| Date Added to Maude | 2013-03-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TORQUE-LIMITING T-HANDLE 7NM |
| Generic Name | TORQUE-LIMITING T-HANDLE 7NM |
| Product Code | GFC |
| Date Received | 2012-12-15 |
| Returned To Mfg | 2012-12-03 |
| Catalog Number | 321.133 |
| Lot Number | 547260N04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-15 |