A photo of the instrument malfunction was provided, which showed one distal compressing arm of the instrument was fractured near the pivot point of the two instrument handles.A functionality assessment was not performed due to the complaint instrument not being returned to the manufacturer.If and/or when the complaint instrument is received, it will be final dispositioned and removed from distributable inventory.A dhr review was performed for the complaint instrument lot, and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/22/2011.The root cause of this complaint cannot be reliably determined.It may be possible that application of excessive compressing force may have contributed to the instrument malfunction.The two handles of the instrument have areas of reduced material to allow for the handles to connect at a pivot point with a lap joint.The instrument fracture location is where one handle transitions from full width to partial width for the lap joint.If excessive compressing force was applied to the instrument handles, it may be possible for the instrument to malfunction as observed.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
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