FDA Adverse Event
Malfunction
Summary report: N
TPS UNIVERSAL DRIVER
MDR report key: 2102547
·
Received May 19, 2011
Report
- Report Number
- 1811755-2011-01834
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS ON GOING; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE STRYKER TPS UNIVERSAL DRIVER WAS SENT IN FOR SERVICE AND IT WAS NOTED THAT IT WAS LEAKING OIL. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TPS UNIVERSAL DRIVER | NONE | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |