FDA Adverse Event
Malfunction
Summary report: N
SYNTHES TI T40 STARDRIVE END CAP
MDR report key: 2181706
·
Received July 21, 2011
Report
- Report Number
- 2181706
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 21, 2011
- Manufacturer
- SYNTHES(USA) LLC
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
Narratives
Description of Event or Problem · 1
DURING THE PROCESS OF SECURING A CLOSED RIGHT SPIRAL TIBIA FIBULA FRACTURE, USING A SYNTHES TITANIUM CANNULATED TIBIAL NAIL EXPERT SYSTEM, THE SURGEON WAS UNABLE TO SECURE THE 10 MM END CAP. IT WAS NOTED THAT THE THREADS MAY BE STRIPPED. THE SURGEON ATTEMPTED PLACEMENT SEVERAL TIMES AND THEN OPTED TO PROCEED WITHOUT THE END CAP. SURGEON STATES NO INJURY TO PATIENT. THE END CAP IS AVAILABLE FOR EVALUATION PURPOSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES TI T40 STARDRIVE END CAP | TI T40 STARDRIVE END CAP F/TIBIAL NAIL 10MM EXT | HSB | SYNTHES(USA) LLC | 04.004.002S | 5535389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |