FDA Adverse Event
Malfunction
Summary report: N
U-BLADE SET, TI 10.5X105MM
MDR report key: 2244769
·
Received September 6, 2011
Report
- Report Number
- 9610622-2011-00423
- Event Type
- Malfunction
- Date Received
- September 6, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K043431
- 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
DURING THE G3 NAIL SURGERY, WHEN THE PACKAGE OF U-LAG SCREW WAS OPENED, IT WAS FOUND THAT THE TWO BLADE OF U-BLADE WAS CROSS AND DEFORMED. AND THE BLADE BROKE WHEN THE SURGEON BENT BLADE IN THE OPPOSITE DIRECTION. THEREFORE, THE SURGEON CHANGED THE U-LAG SCREW TO ANOTHER SIZE U-LAG SCREW. THERE WAS NO ADVERSE PT CONSEQUENCE AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U-BLADE SET, TI 10.5X105MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K106633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Other |