FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2920194
·
Received December 17, 2012
Report
- Report Number
- 1811755-2012-04282
- Event Type
- Malfunction
- Date Received
- December 17, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WITHIN THE MOTOR WAS FOUND TO BE DAMAGED, WHICH IS A PROBABLE CAUSE OF THE BIAS CURRENT ERROR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE DEVICE CAUSED A BIAS CURRENT ERROR TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USE ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |