FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER SHAFT
MDR report key: 1984069
·
Received January 14, 2011
Report
- Report Number
- 2249697-2011-00056
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 23, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "AS THE DOCTOR WAS TWISTING THE SCREWDRIVER TO IMPLANT A 6.5 X 35MM BONE SCREW, THE DISTAL END OF THE DRIVER SHAFT SNAPPED OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER SHAFT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | FXH338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |