FDA Adverse Event
Malfunction
Summary report: N
R/R MICRODRILL STRAIGHT ATT
MDR report key: 1942273
·
Received December 22, 2010
Report
- Report Number
- 1811755-2010-02116
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- 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
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. ACCORDING TO THE INVESTIGATION DETAILS, THE OVERHEATING WAS DUE TO THE LACK OF LUBRICATION IN THE UPPER BEARING. THE DEVICE WAS REPAIRED AND RETURNED TO THE ACCOUNT.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE EXCEEDED MAXIMUM TEMPERATURE DURING TESTING. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R/R MICRODRILL STRAIGHT ATT | BONE CUTTING INSTRUMENT AND ACCESSORIES | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |