FDA Adverse Event
Malfunction
Summary report: N
THE EMAX 2 PLUS SYSTEM
MDR report key: 4150788
·
Received October 8, 2014
Report
- Report Number
- 1045834-2014-13281
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Report Date
- October 22, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- PK080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT BEARINGS WERE DAMAGED DUE TO NORMAL WEAR. ADDITIONALLY, THE FUNCTIONAL TESTING REVEALED THAT THE MOTOR DID NOT REACH THE ROTATIONAL SPEED PER SPECIFICATIONS. DEVICE WAS INSPECTED, AND REPAIRED BY REPLACING A FEW COMPONENTS.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR REPAIR AS THE MOTOR COULD NOT REACH CORRECT ROTATION SPEED. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632924 | THE EMAX 2 PLUS SYSTEM | MOTOR, DRILL, ELECTRIC | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |