FDA Adverse Event
Malfunction
Summary report: N
MICROPOWER SAGITTAL SAW DETACHABLE LEVER
MDR report key: 1034039
·
Received April 24, 2008
Report
- Report Number
- 1017294-2008-00179
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Date of Event
- April 5, 2008
- Report Date
- April 7, 2008
- Manufacturer
- CONMED LINVATEC
- Product Code
- DWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, AN INVESTIGATION OF THE RETURNED SAW HAS NOT BEEN COMPLETED BY CONMED LINVATEC. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING USE OF THIS SAW TO PERFORM FUSION OF A METATARSAL, IT FAILED TO OPERATE PROPERLY. THIS EVENT RESULTED IN A SURGICAL DELAY. IN ADDITION, BECAUSE OF THE DELAY, RADIOGRAPHY WAS NO LONGER AVAILABLE AND THE SURGICAL PROCEDURE HAD TO BE CANCELLED. THERE WAS NO REPORT OF INJURY RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROPOWER SAGITTAL SAW DETACHABLE LEVER | SAGITTAL SAW | DWH | CONMED LINVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NK | LINVATEC UNIVERSAL CABLE| CATALOG #: MC5057 & LOT # NK| CATALOG # & LOT # NK| MICRO SAGITTAL BLADE-COARSE| CATALOG#: 00502314400 & LOT#:BBD45197| MICRO SAGITTAL BLADES FINE |