FDA Adverse Event
Malfunction
Summary report: N
UNK ZIMMER NCB DRILL BIT
MDR report key: 4172359
·
Received October 9, 2014
Report
- Report Number
- 1822565-2014-01307
- Event Type
- Malfunction
- Date Received
- October 9, 2014
- Date of Event
- September 10, 2014
- Report Date
- September 10, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUT INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DRILL BIT FRACTURED. THE FRACTURED PORTION REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636804 | UNK ZIMMER NCB DRILL BIT | TRAUMA INSTRUMENT | HTW | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |