FDA Adverse Event
Malfunction
Summary report: N
HIP 2.3 CURVED SYSTEM
MDR report key: 2183322
·
Received July 28, 2011
Report
- Report Number
- 1219602-2011-00123
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 28, 2011
- Manufacturer
- SMITH & NEPHEW ASDD
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
CUSTOMER OBSERVED SMALL METAL FRAGMENTS PROBABLY IN RELATION WITH THE DRILL. THE BIORAPTOR CURVED 2.3 PK DRILL PART NUMBER 72203160; DRILL GUIDE PART NUMBER IS NOT CONFIRMED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIP 2.3 CURVED SYSTEM | TWIST DRILL,FLEX,CRVD, FOR 2.3 SA | NBH | SMITH & NEPHEW ASDD | 72203160 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |