FDA Adverse Event
Malfunction
Summary report: N
TROCHANTERIC NAIL KIT, TI 11X180MM X 125
MDR report key: 2003070
·
Received February 8, 2011
Report
- Report Number
- 9610622-2011-00045
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 17, 2011
- Report Date
- January 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
SALES REP REPORTED, WHEN OPENING THE STERILE PACKAGING, THEY DISCOVERED A FIBER FROM CLOTHING OR POSSIBLY HAIR. THIS WAS FOUND GLUED BETWEEN THE FILM THAT CONCEAL THE NAIL. THE NAIL WAS THEN PUT ASIDE AND ANOTHER ONE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11X180MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K299376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |