Functional testing of the submitted mbt rev tib 2 deg broache with a retained tibial rod trial found the instruments would not assemble.Broaches utilize o-ring seal (b)(4), which controls the amount of force needed to insert the mating component into the broach.The vendor (tecomet) was contacted and supplied new o-rings for examination.The new o-rings allowed the broach to connect to the mating compent with the appropriate force.The new o-rings were also orange in color and softer than the black o-rings in the complaint products.However, all o-rings should meet the print specification of shore a hardness 50 (durometer specification).A complaint database search against the 217863xxx mbt rev tibial broach family group found additional reports of difficulties of assembly to broaches.The search identified complaints for this failure mode were manufactured in 2004 and 2005.The search did not identify any reports of assembly problems for 217863xxx mbt rev tibial broaches manufactured after 2005.No corrective action is being pursued at this time based on no reported patient harms and the low frequency of reported events.Monitor for complaints with product manufactured after 2005.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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