FDA Adverse Event
Malfunction
Summary report: N
PROFYLE DRILL, DIAM.2.0X100MM, WL 41MM, STRYKER SH
MDR report key: 2002443
·
Received January 28, 2011
Report
- Report Number
- 8010177-2011-00022
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 6, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HBE
- PMA / PMN Number
- K070876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRILL WAS DEFORMED WHEN THE SURGEON DRILLED WITH THE DRILL GUIDE. SO, THE DRILL COULD NOT BE REMOVED FROM THE DRILL GUIDE. THE DRILL STUCK OUT THROUGH PT'S SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFYLE DRILL, DIAM.2.0X100MM, WL 41MM, STRYKER SH | IMPLANT | HBE | STRYKER OSTEOSYNTHESIS FREIBURG | NA | L8601FBZVL/AA05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |