FDA Adverse Event
Malfunction
Summary report: N
KNOB F. TARGET DEVICE 40X50MM
MDR report key: 1915333
·
Received November 17, 2010
Report
- Report Number
- 9610622-2010-00482
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 25, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE KNOB THAT GOES ON TO THE TARGETING ARM WAS NOT FUNCTIONING. IT WAS NOT LOCKING THE LAG SCREW SLEEVE TIGHTLY. WENT THROUGH THE SLEEVE, BUT THE SLEEVE WAS JOSTLING. TARGETING ARM IS SUPPOSED TO LOCK THE LAG SCREW SLEEVE FOR PROPER AIM AND IT WAS MALFUNCTIONING. DR COMPLETED THE SURGERY FREEHAND HOLDING THE SLEEVE MANUALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNOB F. TARGET DEVICE 40X50MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |