The following devices were returned for evaluation: part number 70-0307 "olecranon plate, standard 7-hole rt" batch number 515177 part number 30-0246 "3.5mm x 36mm locking hexalobe screw" batch number 523900 part number 30-0237 "3.5mm x 18mm locking hexalobe screw" batch number 524426 part number 30-0237 "3.5mm x 18mm locking hexalobe screw" batch number 524426 part number 30-0328 "2.7mm x 16mm locking hexalobe screw" batch number 520187 part number 30-0326 "2.7mm x 12mm locking hexalobe screw" batch number 520810 part number 30-0236 "3.5mm x 16mm locking hexalobe screw" batch number 514956 part number 30-0330 "2.7mm x 20mm locking hexalobe screw" batch number 471441 part number 30-0328 "2.7mm x 16mm locking hexalobe screw" batch number 540876 all items were returned in full.The returned parts were examined with magnified photography.The observed phenomena included: [olecranon plate batch 515177] anodization/coloration loss was noted on the underside of the plate by the breakage as well as in several threaded holes and compression slots; holes with anodization loss on the thread also had visible brown discoloration/corrosion.Surface scratching was prevalent.Breakage occurred through the second threaded shaft hole as measured from the cluster; breakage was roughly textured and jagged with no discernable flat/smooth fracture plane or necking/ductility.[36mm screw batch 523900] wear on and in the drive feature.[18mm screw batch 524426 2x] wear on and in the drive feature.Yellow debris present in trough/root of shaft threading; non-corrosive brown discoloration in the shaft threading; bone debris in locking thread.[16mm screw batch 520187] wear on and in the drive feature.[12mm screw batch 520810] wear on and in drive feature.Yellow/bony debris present in locking thread.[16mm screw batch 514956] wear on and in the drive feature.[20mm screw batch 471441] wear on and in the drive feature.[16mm screw batch 540876] wear on and in the drive feature.The returned plate had a highly textured surface indicating that the device failure may have been caused by sudden application of a large load.As the customer event includes no details other than "plate broke post operatively," (e.G.No event specifics, no info on patient physiology/weight, time since implant, patient activity level) the root cause of the reported event could not be determined.
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