FDA Adverse Event
Death
Summary report: N
MAGNA-FX CANNULATED REAMER
MDR report key: 2947000
·
Received January 30, 2013
Report
- Report Number
- 1822565-2013-00200
- Event Type
- Death
- Date Received
- January 30, 2013
- Date of Event
- November 9, 2012
- Report Date
- January 3, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING THE HIP PINNING, WHILE USING THE MAGNA-FIX INSTRUMENTATION, THE GUIDE PIN BECAME JAMMED INSIDE THE CANNULATED REAMER AND WAS ADVANCED INTO THE PATIENT'S PELVIS. TWO ARTERIES WERE SEVERED AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41327 | MAGNA-FX CANNULATED REAMER | HWC | ZIMMER, INC. | 62071978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death | FREE-LOCK FEMORAL FIXATION SYSTEM, CATALOG| #00118102000, LOT # UNK |