BOX CHISEL
Received Aug 19, 2010 · Event occurred Jul 21, 2010
Report 2249697-2010-01116 · MDR key 1815404
Device
Generic name
Instrument
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
6541-4-709
Lot number
PYKJF
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, "REP WAS FOLLOWING UP WITH (B)(6) ON (B)(6) 2010 AND DR MENTIONED THAT HE NOTICED DURING THE PROCEDURE, WHILE CUTTING THE FEMORAL BOX, THAT THERE WAS A CRACK IN THE MEDIAL FEMORAL CONDYLE (BONE). THIS WAS NOT DUE TO THE IMPLANTS, OR ANY OTHER STRYKER PRODUCT. DR RELATED IT TO A SMALL FEMUR AND HARD BONE. DR SPOKE TO REP AND BOTH DECIDED TO REPORT THE INCIDENT, JUST TO GET IT ON RECORD. USED 6.5 PARTIALLY THREADED SCREW TO SECURE THE BONE AND IMPLANTED THE COMPONENTS IN A NORMAL FASHION."
Additional Manufacturer Narrative
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other