FDA Adverse Event
Malfunction
Summary report: N
ECT INTERNAL FRACTURE FIXATION DRILL
MDR report key: 2724688
·
Received August 30, 2012
Report
- Report Number
- 1822565-2012-01856
- Event Type
- Malfunction
- Date Received
- August 30, 2012
- Date of Event
- July 19, 2012
- Report Date
- August 1, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DRILL BIT BROKE OFF IN THE PT. THE TIP WAS NOT RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECT INTERNAL FRACTURE FIXATION DRILL | TRAUMA INSTRUMENT | HTW | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |