FDA Adverse Event
Malfunction
Summary report: N
THE EMAX 2 PLUS SYSTEM
MDR report key: 4122817
·
Received September 26, 2014
Report
- Report Number
- 1045834-2014-13082
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Report Date
- June 6, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- PK080802
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTED THAT SOME COMPONENTS WERE DAMAGED DUE TO IMPROPER HANDLING.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE DEVICE WAS JAMMING AND HEATING. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601671 | THE EMAX 2 PLUS SYSTEM | MOTOR, DRILL, ELECTRIC | HBC | DEPUY SYNTHES POWER TOOLS | E25305102605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |