MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-04-26 for DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA 314.743 manufactured by Synthes (usa).
[463670]
During a procedure for bi-lateral rodding of the femurs for cancerous lesions, the drive shaft and the reamer head were not coupled properly which caused splintering. After the assembly was removed from the pt, it was discovered by fluorscopic image that several metal splinters/flakes in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2006-00053 |
| MDR Report Key | 704823 |
| Report Source | 05,07 |
| Date Received | 2006-04-26 |
| Date of Report | 2006-03-28 |
| Date of Event | 2006-03-20 |
| Date Mfgr Received | 2006-03-28 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-04-28 |
| 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 | 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 |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| 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 | RIA DRIVE SHAFT |
| Product Code | GFC |
| Date Received | 2006-04-26 |
| Model Number | NA |
| Catalog Number | 314.743 |
| Lot Number | 14164-01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 693902 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | * WEST CHESTER PA 19380 US |
| Baseline Brand Name | DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA |
| Baseline Generic Name | RIA DRIVE SHAFT |
| Baseline Model No | NA |
| Baseline Catalog No | 314.743 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-26 |