FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2033734
·
Received March 23, 2011
Report
- Report Number
- 1811755-2011-00911
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVAL; ADD'L INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A STRYKER MICRO SAGITTAL SAW WAS SENT IN FOR REPAIR BECAUSE IT WAS LEAKING OIL DURING A PROCEDURE. IT WAS DISCOVERED ON A TOWEL AWAY FROM THE SURGICAL SITE. NO ADVERSE CONSEQUENCE WAS REPORTED AS A RESULT OF THIS EVENT; THE PROCEDURE WAS COMPLETED WITH ANOTHER SAW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | BONE CUTTING INSTRUMENT AND ACCESSORIES | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |