FDA Adverse Event
Malfunction
Summary report: N
SUPER SUCKER SHORT (BX/20)
MDR report key: 3984173
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-14209
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Report Date
- August 17, 2011
- Manufacturer
- DEPUY SYNTHESES POWER TOOLS
- Product Code
- KDC
- PMA / PMN Number
- K822065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF#: (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAS A "DEVICE IN STERILE PACKAGE" ISSUE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF THERE WAS ANY INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664407 | SUPER SUCKER SHORT (BX/20) | KDC | DEPUY SYNTHESES POWER TOOLS | E153046975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |