FDA Adverse Event
Malfunction
Summary report: N
ZIMMER ZNN CALIBRATED DRILL CANNULATED
MDR report key: 2093268
·
Received May 3, 2011
Report
- Report Number
- 1822565-2011-01103
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- March 21, 2011
- Report Date
- April 4, 2011
- Manufacturer
- ZIMMER INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT WHILE DRILLING OVER THE GUIDE PIN, THE DRILL BIT FRACTURED. AFTER SURGERY AN X-RAY DETERMINED THAT THE FRACTURED PORTION OF THE DEVICE REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER ZNN CALIBRATED DRILL CANNULATED | HTW | ZIMMER INC. | 61581731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |