FDA Adverse Event
Malfunction
Summary report: N
REMB SAG SAW
MDR report key: 2771444
·
Received September 28, 2012
Report
- Report Number
- 1811755-2012-03694
- Event Type
- Malfunction
- Date Received
- September 28, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CORROSION WAS FOUND WITHIN THE MOTOR AND THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WITHIN THE MOTOR WAS FOUND TO BE DAMAGED, WHICH CAN CONTRIBUTE TO DEVICES OPERATING WITHOUT USER ACTIVATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE SAW RAN WITHOUT USER ACTIVATION WHILE IT WAS IN SAFE MODE. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REMB SAG SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |