FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED 4X45 MM
MDR report key: 2002971
·
Received February 8, 2011
Report
- Report Number
- 9610622-2011-00054
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 15, 2011
- Report Date
- January 21, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K003018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, DURING AN IMPLANTATION OF A T2 HUMERAL NAIL, A PROXIMAL LOCKING SCREW WAS IMPLANTED BY THE SURGEON WITHOUT HIS KNOWLEDGE THAT THE STERILITY OF THE SCREW WAS PAST ITS EXPIRATION DATE. IT WAS EXPIRED (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 4X45 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |