FDA Adverse Event
Malfunction
Summary report: N
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
MDR report key: 1884516
·
Received October 21, 2010
Report
- Report Number
- 9610622-2010-00451
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 5, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. HOSPITAL DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, FLEXIBLE SCREW DRIVER SNAPPED OFF INSIDE THE PATIENT. DOCTOR WAS ABLE TO RETRIEVE ALL THE SCREW DRIVER FROM THE PATIENT, AND WAS ABLE TO TIGHTEN THE SCREW USING A COMPETITOR'S SCREW DRIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |