FDA Adverse Event
Malfunction
Summary report: N
STERNUM BLADE
MDR report key: 3902003
·
Received June 30, 2014
Report
- Report Number
- 0001811755-2014-02313
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- January 28, 2014
- Report Date
- June 11, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DWH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE WAS EXTENDING PAST THE STERNUM BLADE GUARD DURING SET UP. IT WAS FURTHER REPORTED THAT THE BLADE BROKE AND WAS DISCARDED. THERE WAS NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE WAS EXTENDING PAST THE STERNUM BLADE GUARD DURING SET UP. IT WAS FURTHER REPORTED THAT THE BLADE BROKE AND WAS DISCARDED. THERE WAS NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380572 | STERNUM BLADE | BLADE, SAW, SURGICAL, CARDIOVASCULAR | DWH | STRYKER INSTRUMENTS-KALAMAZOO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) LOT UNKNOWN (B)(4) LOT 0816101763| (B)(4) LOT UNKNOWN, (B)(4) LOT 0816101763 |