MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-08-14 for DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA 314.743 manufactured by Synthes (usa).
[14870704]
After reaming, surgeon implanted a nail. During distal locking, surgeon noticed a fragment in the medullary canal and left it in the patient. The day after the procedure, the tip of the drive shaft was noted as broken.
Patient Sequence No: 1, Text Type: D, B5
[15390346]
Subject device was received and investigated. The subject device was received with the hex end broken approximately 12mm from the tip. This implies that the drive shaft may have been subjected to excessive over torque. Physical dimensional verification of the device could not be performed due to the missing hex tip. A review of the manufacturing documentation found no complaint related anomalies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2006-00085 |
| MDR Report Key | 772134 |
| Report Source | 05,07 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-07-18 |
| Date of Event | 2006-04-11 |
| Date Mfgr Received | 2006-07-18 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2006-10-24 |
| 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 | 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 | 2006-08-14 |
| Returned To Mfg | 2006-06-27 |
| Model Number | NA |
| Catalog Number | 314.743 |
| Lot Number | 12617-01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 759916 |
| 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 | 2006-08-14 |