FDA Adverse Event
Injury
Summary report: N
11 MM/130 DEG TI CANN TROCH FIXATION NAIL 170 MM
MDR report key: 2234107
·
Received August 29, 2011
Report
- Report Number
- 1719045-2011-00566
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 5, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT WAS RECEIVED IN DECONTAMINATION AND INVESTIGATION IS PENDING.
Description of Event or Problem · 1
PT STATUS POST TFN CASE HAD X-RAYS TAKEN ON AN UNK DATE. X-RAYS SHOWED THAT THE HELICAL BLADE MIGRATED THROUGH THE HEAD OF THE FEMUR. SURGEON REMOVED THE NAIL, BLADE, AND SCREW ON (B)(6) 2011 AND PT WAS REVISED TO HIP REPLACEMENT. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 11 MM/130 DEG TI CANN TROCH FIXATION NAIL 170 MM | 130 DEG TI CANN TROCH FIXATION NAIL | HSB | SYNTHES MONUMENT | 6116862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | BLADE| SCREW |