FDA Adverse Event
Injury
Summary report: N
ZIMMER NATURAL NAIL SYSTEM CORTICAL SCREW
MDR report key: 2082960
·
Received May 3, 2011
Report
- Report Number
- 1822565-2011-01114
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- April 3, 2011
- Report Date
- April 4, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT AFTER THE PROXIMAL SCREW WAS PLACED, X-RAY REVEALED THAT THE SCREW IN THE PROXIMAL DYNAMIC SLOT WAS MALPOSITIONED. THE SURGEON HAD TO MAKE AN INCISION ON THE MEDIAL SIDE AND USE A TAMP AND MALLET TO DRIVE THE SCREW BACK TO A POSITION WHERE A SCREWDRIVER COULD BE USED TO BACK THE SCREW INTO THE PROPER POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER NATURAL NAIL SYSTEM CORTICAL SCREW | HSB | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |