A visual assessment of the returned complaint inserter/compressor showed and instrument with repeated use, as identified by surface scratches and implant engagement interface wear marks.The pin of the instrument distal tip was fractured where it connects with the instrument handle.A functionality assessment was not performed due to the damaged condition of the returned inserter/compressor, which was removed from distributable inventory.It may be possible that application of excessive compression force may have contributed to the instrument's distal tip fracturing from the device.This can be exacerbated by placement of the implant too far anterior, which is where the anatomy slopes.This can cause the instrument to see increased transverse forces on the pin, as well as a bending moment introduced by the implant trying to rest against the anatomy.There has been one other complaint 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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