FDA Adverse Event
Malfunction
Summary report: N
AL-III W/FOOT CONTROL
MDR report key: 3182651
·
Received June 21, 2013
Report
- Report Number
- 1045834-2013-02588
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GEY
- PMA / PMN Number
- K970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE ¿CAME APART¿. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283960 | AL-III W/FOOT CONTROL | MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL | GEY | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |