FDA Adverse Event
Malfunction
Summary report: N
UNI 2 INSTRUMENT SET
MDR report key: 2211079
·
Received August 5, 2011
Report
- Report Number
- 3004608878-2011-00111
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 24, 2011
- Report Date
- August 5, 2011
- Manufacturer
- INTEGRA, CINCINNATI
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE RPTR STATED THAT DURING A PROCEDURE USING THE UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM, IT WAS DISCOVERED THAT TWO COMPONENTS, THE CARPAL GUIDE BARS, WERE MISSING FROM THE INSTRUMENT SET. DURING THE PROCEDURE, THE SURGEON ELECTED TO USE THE RADIAL GUIDE TO IMPROVISE THE CARPAL ALIGNMENT OF THE IMPLANT. THE PT WAS ALREADY INTUBATED FOR GENERAL ANESTHESIA. HAD THE PT NOT BEEN INTUBATED THE SURGEON WOULD HAVE CANCELLED THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNI 2 INSTRUMENT SET | NA | HWC | INTEGRA, CINCINNATI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |