The reported event could be confirmed, since the perform humeral impactor tip size ¾ was returned and found to be broken as stated in the complaint event description.The device inspection revealed the following: the impactor tip shows signs of usage.Several black marks and gouges are visible on the returned device.Brittle fracture damage is evident as noted by minimal plastic deformation and visible confirmation that both pieces can be put back together in perfect alignment.Based on the investigation, the root cause was attributed to wear due to intended use.The failure was caused by intended use.As a device that is manufactured of radel plastic and incurs numerous impaction events, cleaning and sterilization cycles, breakage as noted in this complaint can be expected.No corrective actions are required at this time.However, this event has been escalated to a nc within our quality system for further investigation.A review of the labeling did not indicate any abnormalities.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
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