FDA Adverse Event
Malfunction
Summary report: N
STRAIGHT MEDIUM ELITE ATTACHMENT
MDR report key: 2241641
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03198
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 10, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED, WHICH REVEALED GRITTY BEARING AND FOREIGN DEBRIS CONTAMINATION. THE PRESENCE OF DEBRIS CAN LEAD TO INCREASED FRICTION AMONG ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED.
Description of Event or Problem · 1
DURING TESTING, IT WAS REPORTED THAT THE ATTACHMENT OVER-HEATED. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRAIGHT MEDIUM ELITE ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |