FDA Adverse Event
Malfunction
Summary report: N
U-BLADE SET, TI 10.5X95MM
MDR report key: 2530699
·
Received March 27, 2012
Report
- Report Number
- 9610622-2012-00143
- Event Type
- Malfunction
- Date Received
- March 27, 2012
- Date of Event
- March 6, 2012
- Report Date
- March 7, 2012
- 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
DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(6) 2012, G3U-LAGSCREW OP WAS PERFORMED. AFTER THE INSERTION OF U-BLADE, SURGEON PULLED U-BLADE TO COMPRESSION. THEN AFTER COMPRESSION, HE TRIED INSERTION OF U-BLADE, THE U-BLADE BROKE AT THE PART OF CIRCLE. ONLY A TIP OF THE BLADE WAS A STATE INSERTED ASIDE OF LAGSCREW AND BE HELD WITH ENDCAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U-BLADE SET, TI 10.5X95MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Other |