FDA Adverse Event
Malfunction
Summary report: N
STRAIGHT MEDIUM ELITE ATTACHMENT
MDR report key: 2223263
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03011
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- August 5, 2011
- Report Date
- August 5, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 BEARINGS, CORROSION AND FOREIGN DEBRIS CONTAMINATION. 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
FIELD SERVICE TECHNICIAN STATED THAT THE PRODUCT OVER-HEATED DURING A ROUTINE PROCARE VISIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRAIGHT MEDIUM ELITE ATTACHMENT | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |