FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 2170039
·
Received July 13, 2011
Report
- Report Number
- 8030965-2011-00503
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- December 15, 2010
- Report Date
- June 30, 2010
- Manufacturer
- SYNTHES GMBH
- Product Code
- KTT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
A DEVICE REPORT FROM WALDENBURG INDICATES A CLINIC IN SPAIN REPORTED: PT STATUS POST PFNA 130 DEGREES NAIL IMPLANTATION RETURNED TO SURGEON. AN X-RAY IN (B)(6), 2010 SHOWED THE NAIL BROKE. SURGEON WAS REMOVING THE HARDWARE AND EXPERIENCED PROBLEMS REMOVING THE BLADE WITH THE EXTRACTOR. SURGEON DID REMOVE ALL HARDWARE. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | UNKNOWN | KTT | SYNTHES GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | BLADE| PFNA NAIL |