FDA Adverse Event
Malfunction
Summary report: N
OTISKNEE CUTTING GUIDE - STRYKER - RIGHT
MDR report key: 1624779
·
Received February 19, 2010
Report
- Report Number
- 3005738134-2010-00032
- Event Type
- Malfunction
- Date Received
- February 19, 2010
- Date of Event
- June 25, 2008
- Report Date
- February 10, 2010
- Manufacturer
- OTISMED CORPORATION
- Product Code
- HWT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHODS - PREVIOUS REPORTED EVENT. RESULTS - PREVIOUS REPORTED EVENTS INDICATE A MACRO CHANGE IMPLEMENTED WITHOUT FULL VALIDATION OF EFFECT OF CHANGE. CHANGE NOT EVALUATED BASED IN IMPACT TO CUT FILES AND JIG DESIGN. USE OF MACRO RESULTED IN JD BEING BASED ON INCORRECT PLANNING MODEL.
Description of Event or Problem · 1
THIS IS ONE OF THE OTISKNEE CUTTING GUIDES WHICH WERE NOT MACHINED CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OTISKNEE CUTTING GUIDE - STRYKER - RIGHT | NONE | HWT | OTISMED CORPORATION | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |