FDA Adverse Event
Malfunction
Summary report: N
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
MDR report key: 3051583
·
Received April 10, 2013
Report
- Report Number
- 0001811755-2013-00748
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE UPPER AND LOWER BEARING AND THE UPPER BEARING WAS SHATTERED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS BEING TESTED AT THE MANUFACTURER'S FACILITY WHEN TESTING WAS ABORTED DUE TO THE HANDPIECE WOBBLING AND SHAKING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149318 | MICRO DRILL MEDIUM STRAIGHT ATTACHMENT | DRILL, SURGICAL, ENT (ELECTRIC | ERL | STRYKER INSTRUMENTS-KALAMAZOO | 11131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |