FDA Adverse Event
Malfunction
Summary report: N
AL-III W/FOOT CONTROL
MDR report key: 3963926
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-14826
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Date of Event
- January 27, 2011
- Report Date
- January 27, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GEY
- PMA / PMN Number
- K970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, 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 THE DEVICE HAD A CRACKED PSI GAUGE. THE DEVICE WAS USED DURING SURGERY. NO PT INJURY REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653334 | AL-III W/FOOT CONTROL | GEY | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |