FDA Adverse Event
Malfunction
Summary report: N
2.47MM X 30.3MM SPIRAL ROUTER
MDR report key: 3984152
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-15865
- 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
- HBC
- PMA / PMN Number
- K011444
- 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 3 OF 3. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD DEBRIS IN THE STERILE PACKAGING. 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 |
|---|---|---|---|---|---|---|---|
| 663657 | 2.47MM X 30.3MM SPIRAL ROUTER | HBC | DEPUY SYNTHES POWER TOOLS | E513058747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |