FDA Adverse Event
Malfunction
Summary report: N
DRILL, AO SMALL 4.2 X 300 MM
MDR report key: 2020019
·
Received March 9, 2011
Report
- Report Number
- 9610622-2011-00102
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 20, 2011
- Report Date
- February 20, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, DR OPENED GAMMA TRADITIONALLY. USED CURVED STARTED AWL. COULD NOT BREAK CORTESES. USED DRILL TO ENTER CORTESES TO BE ABLE TO PUT DOWN GUIDE WIRE. UPON PULLING DRILL OUT, DRILL BIT BROKE INSIDE THE PT. SURGEON WAS UNABLE TO REMOVE BIT. SHORT GAMMA NAIL PROCEDURE CONTINUED AS PLANNED. OPERATION CONCLUDED AS SCHEDULED. GAMMA NAIL WENT IN CORRECTLY. REP WILL SEND X-RAY OF DRILL BIT LEFT INSIDE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL, AO SMALL 4.2 X 300 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K571299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |