FDA Adverse Event
Malfunction
Summary report: N
PERFORATOR BIT LARGE 14/11MM
MDR report key: 2062065
·
Received March 16, 2011
Report
- Report Number
- 9616696-2011-00038
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- HBF
- PMA / PMN Number
- K082010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PERFORATOR BIT SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER INFO WAS NOT PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE ON AN ANEURYSM, THE PERFORATOR BIT DID NOT STOP. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFORATOR BIT LARGE 14/11MM | DRILLS, BURS, TREPHINES & ACCESSORIES | HBF | STRYKER IRELAND LTD. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |