FDA Adverse Event
Malfunction
Summary report: N
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION FEMORAL NAIL
MDR report key: 1032403
·
Received April 17, 2008
Report
- Report Number
- 2648920-2008-00024
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Report Date
- March 18, 2008
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JDS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: BECAUSE NONE OF THE PACKAGING WAS RETURNED, IT IS IMPOSSIBLE TO MAKE ANY STATEMENT ABOUT THE PROBABLE CAUSE OF THIS COMPLAINT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. PACKAGING MATERIAL WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS WERE REVIEWED, AND INDICATE THAT THE DEVICE WAS MANUFACTURED AND PACKAGED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT HOSPITAL OR EMPLOYEES STATED PACKAGING WAS NOT INTACT, THEREFORE, WOULD NOT IMPLANT AS COULD NOT PROVE PRODUCT WAS STILL STERILE. EXACT DATE OF OCCURRENCE IS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION FEMORAL NAIL | FEMORAL NAIL | JDS | ZIMMER MANUFACTURING B.V. | NA | 26141200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |