MalfunctionHTT
UNKNOWN PRODUCT
Received Jul 16, 2008 · Event occurred Mar 29, 2007
Report 9610622-2008-00113 · MDR key 1078903
Device
Generic name
Instrument
Manufacturer
Stryker Osteosynthesis KielModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Inadequacy of Device Shape and/or Size
Patient
UNK
- No Information
Narrative
Description of Event or Problem
THE SURGEON, REPORTED THE FOLLOWING ADVERSE DEVICE EVENT: "DISTAL LOCKING SCREW PROBLEMS, AS LATER WAS FOUND OUT BECAUSE OF A WRONG BUR (3.7 AND NOT 4.2 MM).
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Remedial action
- Other