FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 2507095
·
Received March 23, 2012
Report
- Report Number
- 1811755-2012-01060
- Event Type
- Malfunction
- Date Received
- March 23, 2012
- Date of Event
- February 29, 2012
- Report Date
- March 1, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE BEARINGS, WHICH WERE REPLACED ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT HANDPIECE OVERHEATED WHILE THE EQUIPMENT WAS BEING TESTED. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 SAGITTAL SAW | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |