(b)(4).One (1) single inner set screw [product code: 1797-02-000] was returned to the customer quality unit (cqu) for evaluation.Visual examination revealed that the set screw threads had become torn and completely peeled off the body of the set screw.Observed damage suggests that the set screw may likely been not properly seated during insertion and inadvertently cross threading occurred causing the threads to become torn and peeled off.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the single inner set screw threads becoming torn cannot be positively determined.However, the observed damage suggests that the set screw may likely been not properly seated during insertion and inadvertently cross threading occurred causing the threads to become torn and peeled off.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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