An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the review by the packaging engineering department the inner blister the pack may only become damaged if the pack was dropped either prior to outer blister packaging by the packaging operator, or upon opening in the or by theatre staff.On review of the process in the metals clean room the only way this damage could have occurred would be if the skin pack was dropped.However the skin pack would be inspected per (b)(4) " procedure for evaluation of sterile barrier system seal integrity." and if any discrepancy was noted the part would be re skin packed.In the or, it is common practice to 'drop' the inner pack from the outer pack, onto the sterile prep table.It is possible that the inner pack became damaged if it was accidently dropped onto a device (instrument,tray, etc.)already on the sterile prep table.As stated, there are two possible causes of this occurrence, but neither are conclusive.-medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: there have been no other events for the lot referenced.Conclusions: based on the review by the packaging engineering department, there are two possible causes of this occurrence, the inner blister was dropped either prior to outer blister packaging by the packaging operator, or upon opening in the or by theatre staff.Neither are conclusive.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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