FDA Adverse Event
Malfunction
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12
MDR report key: 2617602
·
Received June 6, 2012
Report
- Report Number
- 9610622-2012-00242
- Event Type
- Malfunction
- Date Received
- June 6, 2012
- Date of Event
- May 10, 2012
- Report Date
- May 14, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WIL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE WITH THIS EVENT: (B)(4) LAG SCREW, TI GAMMA3 10.5 X 100 MM, LOT # K859240. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 45 MM, LOT # K284341. (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5 X 52,5MM, LOT #K851267.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "ACCIDENTALLY A LEFT LONG GAMMA NAIL WAS OPENED AND IMPLANTED INTO A RIGHT FEMUR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11 X 360MM X 12 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K593991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |