FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 3140642
·
Received May 31, 2013
Report
- Report Number
- 0001811755-2013-01267
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- May 10, 2013
- Report Date
- May 13, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K943540
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION, WORN WEDGES WERE FOUND.
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
WHILE TESTING THE TPS HANDPIECE CORD, IT CAUSED THE HANDPIECE TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Description of Event or Problem · 1
WHILE TESTING THE TPS HANDPIECE CORD, IT CAUSED THE HANDPIECE TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242258 | TPS HANDPIECE CORD | DRIVER, WIRE, AND BONE DRILL, MANUAL | DZJ | STRYKER INSTRUMENTS-KALAMAZOO | 11231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW, SERIAL NUMBER (B)(4) |