FDA Adverse Event
Malfunction
Summary report: N
1.85MM X 16MM FLUTED ROUTER
MDR report key: 3984134
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-15866
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- June 25, 2012
- Report Date
- August 10, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GFF
- PMA / PMN Number
- K974025
- 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 ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT 1 OF 2. SYNTHES (B)(4) NOTIFIED ANSPACH ABOUT RETURN OF GRE-1 FOR PACKAGING DEFECTS THAT WERE FOUND DURING INCOMING VISUAL CHECK. IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. IT IS ALSO KNOWN THAT THERE WAS NO PT/USER INJURY OR MEDICAL INTERVENTION. IF ANY ADD'L INFO SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663651 | 1.85MM X 16MM FLUTED ROUTER | GFF | DEPUY SYNTHES POWER TOOLS | E293052988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |