FDA Adverse Event
Malfunction
Summary report: N
DVRA R RIGHT
MDR report key: 771057
·
Received August 10, 2006
Report
- Report Number
- 1818910-2006-02384
- Event Type
- Malfunction
- Date Received
- August 10, 2006
- Date of Event
- May 17, 2006
- Report Date
- July 18, 2006
- Manufacturer
- HAND INNOVATIONS, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE K-WIRE GOT STUCK IN THE DEDICATED DISTAL HOLE OF THE PLATE. THE SURGEON WAS NOT ABLE TO REMOVE THE WIRE, WHICH GOT BROKEN INTO THE HOLE AS YOU CAN SEE FROM THE SAMPLE. THE SURGERY WAS EXTENDED 20 MINS DUE TO THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DVRA R RIGHT | PLATE | HRS | HAND INNOVATIONS, INC. | NA | 28030522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |