FDA Adverse Event
Injury
Summary report: N
NATURAL KNEE SYSTEM POLY PATELLA STOP DRILL
MDR report key: 1841526
·
Received September 14, 2010
Report
- Report Number
- 1822565-2010-00690
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- August 11, 2010
- Report Date
- August 11, 2010
- Manufacturer
- ZIMMER INC.
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE STOP ON THE DRILL BIT IS NOT ENGAGING WHICH COULD ALLOW THE SURGEON TO COMPLETELY DRILL THROUGH THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL KNEE SYSTEM POLY PATELLA STOP DRILL | KNEE INSTRUMENT | HTW | ZIMMER INC. | 61015149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Other | NATURAL KNEE SYSTEM PETALLA BUSHING| LOT #61040228, CATALOG #629000750| NATURAL KNEE SYSTEM POLY PATELLA DRILL GUIDE| LOT #0796408, CATALOG #629000690 |