FDA Adverse Event
Malfunction
Summary report: N
STERILIZATION CASE & TRAY, XMAX
MDR report key: 3981596
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-16155
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- August 10, 2012
- Report Date
- August 20, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
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 ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.
Description of Event or Problem · 1
REPORT 1 OF 5. REPORT RECEIVED FROM (B)(6), STATING THAT THE DEVICE HAD DEBRIS IN STERILE PACKAGE. THE DEVICE WAS NOT BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663238 | STERILIZATION CASE & TRAY, XMAX | HBC | DEPUY SYNTHES POWER TOOLS | F283066398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |