FDA Adverse Event
Injury
Summary report: N
ACUFEX MOSAICPLASTY 4.5MM TUBULAR CHISEL
MDR report key: 114711
·
Received August 20, 1997
Report
- Report Number
- 1219602-1997-00071
- Event Type
- Injury
- Date Received
- August 20, 1997
- Date of Event
- May 15, 1997
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- KDG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DISTAL END OF BONE CHISEL BROKE OFF IN KNEE. BROKEN PIECE WAS EMBEDDED TO PREVENT IMPINGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUFEX MOSAICPLASTY 4.5MM TUBULAR CHISEL | BONE CHISEL | KDG | SMITH & NEPHEW, INC. | NA | 196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |