FDA Adverse Event
Malfunction
Summary report: N
REMB SAG SAW
MDR report key: 3021381
·
Received March 26, 2013
Report
- Report Number
- 0001811755-2013-00602
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 20, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL EXAMINATION, THE DEVICE CONTAINED MULTIPLE BROKEN/DISASSEMBLED COMPONENTS INCLUDING THE FRONT HOUSING AND THE YOKE.
Description of Event or Problem · 1
THE REM B SAG SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND THAT PART OF THE BLADE WAS BROKEN OFF IN THE BLADE MOUNT. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123890 | REMB SAG SAW | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN STRYKER BLADE |