FDA Adverse Event
Injury
Summary report: N
PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA
MDR report key: 499434
·
Received December 5, 2003
Report
- Report Number
- 1822565-2003-00200
- Event Type
- Injury
- Date Received
- December 5, 2003
- Report Date
- October 31, 2003
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WHILE REAMING OVER A 3.0 MM GUIDE PIN, REAMER HEAD BROKE OFF. PIECES OF THE REAMER SHAFT WERE LEFT IN THE PT.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |