FDA Adverse Event
Malfunction
Summary report: N
GUIDE WIRE CAGE
MDR report key: 2444086
·
Received January 18, 2012
Report
- Report Number
- 9610622-2012-00021
- Event Type
- Malfunction
- Date Received
- January 18, 2012
- Date of Event
- December 24, 2011
- Report Date
- December 27, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE ASSOCIATED DEVICE IN THIS EVENT IS (B)(4) GUIDE WIRE HANDLE CHUCK 2-3, 5 MM K534018 LOT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE BALL TIP GUIDE WIRE WOULD NOT FIT THROUGH THE T-HANDLE. THE SCRUB TECH TRIED SEVERAL TIMES AND EACH TIME IT WOULD NOT GO THROUGH. WE ENDED UP OPENING ANOTHER INSTRUMENT SET AND USED THAT T-HANDLE TO COMPLETE THE CASE SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDE WIRE CAGE | INSTRUMENT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | K764736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |