FDA Adverse Event
Malfunction
Summary report: N
OSTEOSTAT STERNAL SAW
MDR report key: 142621
·
Received January 9, 1998
Report
- Report Number
- 2219689-1998-00005
- Event Type
- Malfunction
- Date Received
- January 9, 1998
- Date of Event
- December 1, 1997
- Report Date
- January 7, 1998
- Manufacturer
- SURGIQUIP INC
- Product Code
- DWH
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE STERNAL SAWS WOULD NOT ALLOW FOR 180 DEGREE BLADE TURN. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOSTAT STERNAL SAW | INSTRUMENT | DWH | SURGIQUIP INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |