FDA Adverse Event
Malfunction
Summary report: N
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
MDR report key: 2212100
·
Received July 8, 2011
Report
- Report Number
- 9610622-2011-00307
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THROUGH OUR CUSTOMER SERVICE REPRESENTATIVE, AN EVENT RELATED TO THE BREAKAGE OF THE PRODUCT INVOLVED. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. NO ADVERSE CONSEQUENCES REPORTED BY THE USER. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER ITEM AVAILABLE IN THE THEATRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K280611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |