FDA Adverse Event
Malfunction
Summary report: N
ANGLED MEDIUM ELITE ATTACHMENT
MDR report key: 2241661
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03201
- 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 CORROSION AND FOREIGN DEBRIS CONTAMINATION WITHIN THE DEVICE, INCLUDING THE BEARINGS. THE PRESENCE OF CORROSION AND 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 | ANGLED MEDIUM ELITE ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |