FDA Adverse Event
Malfunction
Summary report: N
STANDARD CRANIOTOME, BLACK MAX
MDR report key: 3163000
·
Received June 11, 2013
Report
- Report Number
- 1045834-2013-02439
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- July 28, 2011
- Report Date
- August 2, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GFF
- PMA / PMN Number
- K974025
- 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)(6), STATING THAT THE "CUTTER GOT STUCK INSIDE" THE DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262263 | STANDARD CRANIOTOME, BLACK MAX | BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME | GFF | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |