FDA Adverse Event
Malfunction
Summary report: N
K WIRE DIAM 1.6MM LG 200MM 1 SHARP END BLUNT
MDR report key: 3022906
·
Received March 20, 2013
Report
- Report Number
- 9615741-2013-00011
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- NEWDEAL SAS
- Product Code
- HTY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE RPTR NOTED "THE K-WIRE SENT IN THE LARGE QWIX SET WERE NOT 200MM AS DESCRIBED ON THE BOX. THEY WERE APPROX 230MM WHICH ARE THROWING OFF MEASUREMENTS BY 30MM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115327 | K WIRE DIAM 1.6MM LG 200MM 1 SHARP END BLUNT | QUIX | HTY | NEWDEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |