FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 1945882
·
Received December 28, 2010
Report
- Report Number
- 1811755-2010-02139
- Event Type
- Malfunction
- Date Received
- December 28, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OIL-LIKE SUBSTANCE LEAKED OUT OF THE HANDPIECE DURING THE CLEANING PROCESS. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |