A visual assessment of the returned system implant inserter showed an instrument with repeated use, as identified by surface scratches, worn laser markings, corrosion, and implant inserter tip engagement wear marks.The implant inserter drawbar was fractured proximal to the boss that engages with the implant inserter tip.A functionality assessment was not performed due to the damaged condition of the implant inserter, which was removed from distributable inventory.A dhr review was performed for complaint lot#: 045211 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 1/28/2016.The damaged drawbar of the implant inserter prevents it from functioning as intended for implant inserter tip engagement.It is unknown how the drawbar of the implant inserter was damaged.It may be possible that excessive force placed on the implant inserter drawbar could have contributed to the instrument malfunction.It could also be possible that an implant inserter tip may have got stuck in the implant inserter at some point, and in an attempt to remove the inserter tip, the drawbar could have been damaged.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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