FDA Adverse Event
Malfunction
Summary report: N
EHD STERNUM
MDR report key: 2621643
·
Received June 12, 2012
Report
- Report Number
- 1811755-2012-02217
- Event Type
- Malfunction
- Date Received
- June 12, 2012
- Date of Event
- February 27, 2012
- Report Date
- February 28, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DWG
- PMA / PMN Number
- K863447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO STRYKER INSTRUMENTS FOR EVALUATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICES EHD STERNUM SAW'S CABLE OVERHEATED DURING TESTING AT THE MANUFACTURER'S INTERNATIONAL SUBSIDIARY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EHD STERNUM | DWG | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |