FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°
MDR report key: 3982412
·
Received August 6, 2014
Report
- Report Number
- 0009610622-2014-00390
- Event Type
- Injury
- Date Received
- August 6, 2014
- Date of Event
- July 9, 2014
- Report Date
- July 9, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT HAD PRIMARY SURGERY APPROX. SIX MONTHS AGO FOR A HIP FRACTURE. PATIENT WAS REVISED. AS PER SALES REP, GAMMA NAIL BROKE AT JUNCTION OF LAG SCREW AND GAMMA NAIL. DOCTOR TOOK OUT LOCKING SCREW 5 X 35.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460837 | TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120° | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER TRAUMA KIEL | K170578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |