FDA Adverse Event
Malfunction
Summary report: N
11.0 CM LONG ATTACHMENT
MDR report key: 3811260
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-13989
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- June 8, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 THE USA STATED THE DEVICE HAD DAMAGED BEARINGS. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524124 | 11.0 CM LONG ATTACHMENT | MOTOR, DRILL, ELECTRIC - ATTACHMENT | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |