FDA Adverse Event
Malfunction
Summary report: N
TROCHANTERIC NAIL KIT, TI 11 X 180 MM X 130
MDR report key: 2192504
·
Received June 30, 2011
Report
- Report Number
- 9610622-2011-00285
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- April 10, 2008
- Report Date
- June 14, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
AN (B)(4) REPORT HAS BEEN SENT, WHICH STATES: "DISTAL LOCKING SCREW MALPOSITION (NOT THROUGH THE NAIL). BURRING FOR A SECOND TIME AFTER WHICH THE SCREW WAS IN THE RIGHT PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI 11 X 180 MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K518768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |