FDA Adverse Event
Malfunction
Summary report: N
LOANER CORE SAG SAW
MDR report key: 3072845
·
Received April 23, 2013
Report
- Report Number
- 0001811755-2013-00870
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 27, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON EVALUATION, THE MOTOR AND PRESS PLUG WERE REPLACED DUE TO THE ERROR MESSAGE. PREVENTATIVE MAINTENANCE WAS PERFORMED AND DUE TO THE DEVICE LOANER STATUS, THIS DOES NOT REQUIRE RETURN.
Description of Event or Problem · 1
THE CORE SAG SAW WAS RETURNED AFTER THE ACCOUNT RECEIVED THEIR OWN DEVICE BACK FROM REPAIR. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE SIGNALING A CONDITION OCCURED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175667 | LOANER CORE SAG SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |