FDA Adverse Event
Malfunction
Summary report: N
RIA TUBE ASSEMBLY MIN 520MM
MDR report key: 1071860
·
Received July 8, 2008
Report
- Report Number
- 1719045-2008-00085
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 12, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HTO
- PMA / PMN Number
- K013527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT NOR ON THE COMPLETED QUESTIONNAIRE RECEIVED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
DURING A TFN PROCEDURE TO TREAT A RIGHT FEMORAL TRANSVERSE FRACTURE, THE RIA CAME APART WHILE IN THE FEMORAL CANAL. THE RIA AND REAMER HEAD WERE REMOVED, BUT METAL DEBRIS WAS LEFT IN THE CANAL. THE SURGEON COMPLETED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIA TUBE ASSEMBLY MIN 520MM | REAMER/IRRIGATOR/ASPIRATOR SYSTEM | HTO | SYNTHES MONUMENT | NA | 5629553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | GUIDE WIRE| REAMER HEAD |