FDA Adverse Event
Malfunction
Summary report: N
MOVEMENT GREAT TOE INSTRUMENTS
MDR report key: 2498333
·
Received March 15, 2012
Report
- Report Number
- 1651501-2012-00024
- Event Type
- Malfunction
- Date Received
- March 15, 2012
- Report Date
- March 15, 2012
- Manufacturer
- ASCENSION ORTHOPEDICS
- Product Code
- KWD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT NOT EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
SET RECEIVED FOR CASE WAS SENT WITH WRONG K-WIRES IN IT; K-WIRES WERE TOO LONG AND DIDN'T HAVE THE LASER CALIBRATION MARKINGS ON IT. THERE WAS A 10 MINUTE DELAY IN SURGERY AS A RESULT OF THE PHYSICIAN NEEDING TO FIGURE OUT EXACTLY WHAT MEASUREMENT(S) THE LASER MARKINGS HAD TO BE PLACED AT, IN ORDER TO CALIBRATE INSTRUMENTS TO IMPLANT SPECIFICATIONS AFTER CALLING MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOVEMENT GREAT TOE INSTRUMENTS | MOVEMENT GREAT TOE | KWD | ASCENSION ORTHOPEDICS | GT12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |