FDA Adverse Event
Injury
Summary report: N
PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA
MDR report key: 449484
·
Received March 19, 2003
Report
- Report Number
- 1822565-2003-00033
- Event Type
- Injury
- Date Received
- March 19, 2003
- Date of Event
- February 14, 2003
- Report Date
- February 17, 2003
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REAMER WAS BROKEN WHILE REAMING THE TIBIA. SINCE SURGEON COULD NOT EXTRACT THE DEVICE, SURGEON MADE A HOLE ON THE LOWER TIBIA AND EXTRACTED THE GUIDWIRE. AFTER SURGEON REMOVED THE ROUND BALL ON THE TIP OF THE GUIDEWIRE WITH A PIN CUTTER, SURGEON INSERTED THE OTHER REAMER THROUGH THE GUIDEWIRE AND TRIED TO PUSH THE BROKEN REAMER FROM DISTAL TO PROXIMAL. ALTHOUGH SURGERY WAS EXTENDED 2 HOURS AND THE PT RECEIVED AN UNEXPECTED INJURY ON THE LOWER TIBIA, THE BROKEN REAMER WAS EXTRACTED AND SURGERY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA | FLEXIBLE REAMER | HTO | ZIMMER, INC. | NA | 74705300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization| R |