FDA Adverse Event
Malfunction
Summary report: N
BLACKMAX-NEURO LOW PRESSURE
MDR report key: 3182078
·
Received June 21, 2013
Report
- Report Number
- 1045834-2013-02568
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- September 12, 2011
- Report Date
- October 4, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HSZ
- PMA / PMN Number
- K831756
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.(B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(4) STATING THAT THE DEVICE WAS RUNNING INTERMITTENTLY. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282240 | BLACKMAX-NEURO LOW PRESSURE | INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED - HANDPIECE | HSZ | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |