FDA Adverse Event
Malfunction
Summary report: N
GUIDE WIRE, SMOOTH-TIPPED, STERILE 2,2X800 MM
MDR report key: 1984056
·
Received January 14, 2011
Report
- Report Number
- 9610622-2011-00021
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- November 14, 2010
- Report Date
- December 28, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE RISK MANAGER FROM THE HOSPITAL, REPORTED THE ALLEGED EVENT, THE DEVICE CANNOT BE USED BECAUSE THE GUIDE WAS BENT INSIDE THE PACKAGING BUT NO DELAY DURING THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDE WIRE, SMOOTH-TIPPED, STERILE 2,2X800 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K290833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |