FDA Adverse Event
Malfunction
Summary report: N
SC2000
MDR report key: 3811303
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-13330
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- December 14, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM USA, STATING THAT THE DEVICE HAD "DAMAGED WIRING". IT IS UNK IF THE EVENT OCCURRED DURING SURGERY. IT IS UNK IF THERE WAS ANY PT OR USER INJURY, SURGICAL DELAY OR MEDICAL INTERVENTION REPORTED RELATED TO THIS OCCURRENCE. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523871 | SC2000 | MOTOR, DRILL, ELECTRIC - CONSOLE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |