FDA Adverse Event
Death
Summary report: N
THREADED GUIDE WIRE ASNIS III 3.2X300MM
MDR report key: 2834116
·
Received November 7, 2012
Report
- Report Number
- 8031020-2012-00266
- Event Type
- Death
- Date Received
- November 7, 2012
- Date of Event
- October 20, 2012
- Report Date
- October 22, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE TREATING SURGEON REPORTED THAT WHEN REAMING THE CORTICAL LAYER OVER THE IN-SITU K-WIRE, IT JAMMED AND ADVANCED INTO IN THE SMALL PELVIS. LATER, INTRA-ABDOMINAL HEMORRHAGING OCCURRED. THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THREADED GUIDE WIRE ASNIS III 3.2X300MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death| O |