FDA Adverse Event
Malfunction
Summary report: N
REPAIR TPS SAG SAW
MDR report key: 1853480
·
Received September 28, 2010
Report
- Report Number
- 1811755-2010-01271
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Date of Event
- August 20, 2010
- Report Date
- September 2, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE BOTTOM ROTOR BEARING BROKE IN THE MOTOR AND THE ROTOR WAS CORRODED. THE ROTOR, FRONT HOUSING AND MOTOR CARTRIDGE WERE REPLACED, ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING TESTING OF THE EQUIPMENT. THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR TPS SAG SAW | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |