MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-03-20 for DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA 314.743 manufactured by Synthes (usa).
[836467]
Surgeon reported reamer head broke off from the drive shaft while harvesting bone graft from the femoral canal. The reamer head was retrieved and procedure was completed with a different assembly. Metal shards were noted in bone graft material and the femoral canal.
Patient Sequence No: 1, Text Type: D, B5
[8049579]
Subject device is an instrument and is not implanted. The drive shaft was found with approximately 15 mm of the hex end broken with wear on the helix and in area adjacent to the tube adapter when assembled. There is slight deformation on the flats for jacob's chuck connection. Visual examination of the tube assembly revealed a small metal fragment of the drive shaft lodged in the tube. It is difficult of determine the actual cause of the complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2008-00023 |
| MDR Report Key | 1017055 |
| Report Source | 05,07 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-02-22 |
| Date of Event | 2007-12-13 |
| Date Mfgr Received | 2008-02-22 |
| Device Manufacturer Date | 2005-06-02 |
| Date Added to Maude | 2008-06-19 |
| 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 Contact | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | MONUMENT MAIN FINISHED GOODS |
| 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 | DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA |
| Generic Name | NONE |
| Product Code | GFC |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-02-05 |
| Model Number | NA |
| Catalog Number | 314.743 |
| Lot Number | 13928-01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1014636 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA 19380 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-20 |