FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 2241649
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03214
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 11, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE LEAKING WAS DUPLICATED. A SAMPLE WAS TAKEN FROM THE SAG HEAD. SERVICE WILL COMPLETE ANY NECESSARY MAINTENANCE OR REPAIRS AND THEN RETURN THE DEVICE TO THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING A LIGHT GRAY OIL SUBSTANCE DURING THE CLEANING PROCESS. THERE WAS NO PATIENT 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 |