FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2121133
·
Received May 4, 2011
Report
- Report Number
- 1811755-2011-01573
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 8, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY THE MANUFACTURER. THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE AND THERE WAS EXCESSIVE NOISE COMING FROM THE MOTOR. THERE WAS INSUFFICIENT LUBE IN THE BEARINGS ON THE ROTOR ASSEMBLY AND DRIVESHAFT ASSEMBLY. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT WAS GETTING HOT DURING A WISDOM TOOTH EXTRACTION. THE CUSTOMER HAD ANOTHER UNIT 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 | CORE IMPACTION DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |