A visual assessment of the returned complaint inserter/compressor showed an instrument with minimal use, as identified by crisp laser markings and a lack of surface scratches.The male spring of the inserter/compressor was broken at approximately the middle of the spring a functionality assessment was not performed due to the damaged condition of the returned system inserter/compressor, which was removed from distributable inventory.A dhr review was performed for the instrument complaint 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 2/10/2021.The root cause of this complaint cannot be reliably determined.The complaint investigation suggests it may be possible for the male spring of a system inserter/compressor to be broken if the 420 stainless steel was bent.The male spring of the system inserter/compressor could be bent if the male and female spring did not appropriately engage during compression, or if it were bent physically to get additional handle resistance.There has been one other complaint of a similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
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