FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRILL
MDR report key: 2241659
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03199
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 17, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DRILL WAS RECEIVED BY THE MANUFACTURER, HOWEVER THE COMPLAINT COULD NOT BE REPLICATED. BASED ON THE RESULTS OF THE DEVICE EVALUATION, THE DRILL PERFORMED ACCORDING TO ALL SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT CONTINUES TO RUN AFTER THE FOOT PEDAL IS RELEASED. ANOTHER DRILL WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |