FDA Adverse Event
Malfunction
Summary report: N
DRILL GUIDE PILOT TIP
MDR report key: 1972671
·
Received January 20, 2011
Report
- Report Number
- 1038671-2011-00007
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 15, 2010
- Report Date
- January 20, 2010
- Manufacturer
- EXACTECH INC.
- Product Code
- FZX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ENGINEERING EVAL OF RETURNED INSTRUMENT PENDING.
Description of Event or Problem · 1
DURING A TOTAL HIP ARTHROPLASTY THE PILOT WHICH ATTACHES TO THE DRILL GUIDE DISASSEMBLED AND FELL INTO THE FEMORAL CANAL. EVENT WAS NOTICED IMMEDIATELY AND SURGEON ATTEMPTED TO RETRIEVE WITHOUT SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL GUIDE PILOT TIP | FZX | EXACTECH INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |