FDA Adverse Event
Malfunction
Summary report: N
SET SCREW, TI GAMMA3 8X17.5MM
MDR report key: 2651056
·
Received June 27, 2012
Report
- Report Number
- 9610622-2012-00290
- Event Type
- Malfunction
- Date Received
- June 27, 2012
- Date of Event
- June 4, 2012
- Report Date
- June 19, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE: TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125, 3125-1200S, LOT # K159627.
Description of Event or Problem · 1
THE NURSE REPORTED TO OUR SALES REP THAT SHE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS, SHE OBSERVED THAT THE SET SCREW GET JAMMED IN THE NAIL. THERE WAS A DELAY OF 5 MIN. A REPLACEMENT WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREW, TI GAMMA3 8X17.5MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |