FDA Adverse Event
Other
Summary report: N
GUIDE WIRE, BALL-TIPPED 2.5X800 MM
MDR report key: 2155614
·
Received June 30, 2011
Report
- Report Number
- 9610622-2011-00289
- Event Type
- Other
- Date Received
- June 30, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED, SURGEON WAS PUTTING IN BILATERAL GTN'S. HE USES A 2.5 BALL TIP GUIDE WIRE FOR ALL HIS NAILS (1806-0083'S). HE PUT THE 2.5 BALL TIP WIRE DOWN THE FEMORAL CANAL AND PLACED A 8MM GTN OVER THE WIRE. WHEN HE WENT TO PULL THE BALL TIP WIRE OUT OF THE CANAL, THE WIRE WOULD NOT GO THRU THE 8MM NAIL. HE HAD TO REMOVE THE NAIL TO GET THE BALL TIP WIRE OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDE WIRE, BALL-TIPPED 2.5X800 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K170731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |