FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130
MDR report key: 2798717
·
Received October 17, 2012
Report
- Report Number
- 9610622-2012-00462
- Event Type
- Injury
- Date Received
- October 17, 2012
- Date of Event
- September 24, 2012
- Report Date
- September 24, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICES: LAG SCREW, TI GAMMA3 10.5X105MM, LOT #K920929, 3060-0105S; LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM, LOT # K909359, 1896-5040S.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON IMPLANTED A GAMMA NAIL IN (B)(6) 2012 - SURGEON PUT IN A GAMMA SHORT NAIL (X-RAYS INCLUDED). ON (B)(6), PT FELL AND WENT TO DOCTOR COMPLAINING OF SHOULDER AND RIB PAIN AND DOCTOR SAID PT WAS OK. TWO WEEKS LATER (B)(6) PT ARRIVED IN THE EMERGENCY ROOM WITH A SUBTROCHANTERIC AND INTER TROCHANTER FRACTURE AND BROKEN NAIL AT THE JUNCTION OF THE LAG SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K124274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |