Upon visual inspection no damage was noted on the instrument that would contribute to the complaint condition.A functional test was performed, and the main body was seized which would prevent it from interacting properly with the rest instrument and this the complaint is confirmed.The complaint condition was confirmed for the instrument.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for compressor/distractor rack was conducted identifying that lot number gm4059402 was released in a single batch.Batch1: lot qty of units were released on 04 apr 2014 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch: null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed.
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