FDA Adverse Event
Injury
Summary report: N
10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM
MDR report key: 2862608
·
Received December 10, 2012
Report
- Report Number
- 1719045-2012-01281
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING HAS BEEN REQUESTED.
Description of Event or Problem · 1
THE PATIENT HAD A TFN IMPLANT ON (B)(6) 2012. ON AN UNKNOWN DATE, THE SURGEON DISCOVERED BY X-RAY THAT THE HELICAL BLADE WAS FLUSH WITH THE NAIL AND WAS STICKING UP THROUGH THE HEAD INTO THE SOCKET. THE PATIENT UNDERWENT A TFN REVISION ON (B)(6) 2012. THE SURGEON DID NOT HAVE A REASON FOR THIS EVENT. THIS REPORT IS NUMBER 1 OF 3 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM | 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM | HSB | SYNTHES MONUMENT | 696628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | SCREW, HELICAL BLADE |