FDA Adverse Event
Malfunction
Summary report: N
TPS UNIVERSAL DRIVER
MDR report key: 3032124
·
Received April 3, 2013
Report
- Report Number
- 0001811755-2013-00683
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 11, 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 THE DRIVE SHAFT AND BEARINGS WERE WORN.
Description of Event or Problem · 1
THE TPS UNIVERSAL DRIVER WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER IT DISPLAYED A BIAS CURRENT WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136636 | TPS UNIVERSAL DRIVER | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |