MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-08-23 for DRIVE SHAFT MINIMUM 520MM LENGTH 314.743 manufactured by Synthes (usa).
[22054374]
No investigation could be performed, no conclusion could be drawn as no device was returned.
Patient Sequence No: 1, Text Type: N, H10
[22184360]
During a procedure, the tip of the drive shaft broke during reaming of the intermedullary canal. A post operative x-ray revealed that a small fragment was left in the patient. Currently, the surgeon does not have plans to remove the fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2007-00062 |
| MDR Report Key | 901645 |
| Report Source | 05,07 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-02 |
| Date of Event | 2007-06-17 |
| Date Mfgr Received | 2007-08-02 |
| Device Manufacturer Date | 2007-03-14 |
| Date Added to Maude | 2007-10-03 |
| 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 | CHARISSE BALL |
| 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 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 |
| Generic Name | RIA DRIVE SHAFT |
| Product Code | GFC |
| Date Received | 2007-08-23 |
| Returned To Mfg | 2007-08-22 |
| Model Number | NA |
| Catalog Number | 314.743 |
| Lot Number | 14780-01 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 880166 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA 19380 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-23 |