FDA Adverse Event
Malfunction
Summary report: N
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW
MDR report key: 1173503
·
Received September 25, 2008
Report
- Report Number
- 2242816-2008-00134
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- January 31, 2007
- Report Date
- September 24, 2008
- Manufacturer
- EBI, LLC
- Product Code
- HWC
- PMA / PMN Number
- K984209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS A RESULT OF A RETROSPECTIVE REVIEW OF THE COMPLAINT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE GUIDE WIRE WAS NOT ABLE TO PASS THROUGH THE CANNULATED SCREW. AN ADDITIONAL SCREW WAS AVAILABLE AND WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW | SCREW, FIXATION, BONE | HWC | EBI, LLC | 010277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |