FDA Adverse Event
Malfunction
Summary report: N
SINGLE TRIGGER ROTARY
MDR report key: 2758206
·
Received September 18, 2012
Report
- Report Number
- 1811755-2012-03536
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- August 22, 2012
- Report Date
- August 22, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SWITCHED FROM THE FORWARD MODE TO THE REVERSE MODE DURING USE AS A RESULT OF AN EBOX/TOGGLE MAGNETIC INTERACTION ISSUE.
Description of Event or Problem · 1
THE SINGLE TRIGGER ROTARY WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS AT THE MFR, IT WAS FOUND THAT THE DEVICE RUNS IN FORWARD WHILE IN REVERSE MODE. NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE TRIGGER ROTARY | KIJ | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |