FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER SHAFT
MDR report key: 1981620
·
Received January 12, 2011
Report
- Report Number
- 2249697-2010-01933
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 7, 2010
- Report Date
- December 7, 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
- JA
- 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, "DURING THE THA, THE SURGEON WAS USING THE UNIVERSAL DRIVER SHAFT, THE TIP OF IT WAS BROKEN. THE SURGEON COULD NOT REMOVE A FRAGMENT OF TIP FROM SCREW HEAD. THEREFORE, HE IMPLANTED A INSERT WITHOUT REMOVING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER SHAFT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | F5A9383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |