Three (3) expedium 4.5 ti single innie set screws [product codes: 1861-00-001] were returned to the customer quality unit (cqu) for evaluation.Visual examination revealed that set screw (lot number rl202295) and set screw (lot number illegible) had torn threads.Observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.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.No emerging trends were found requiring further actions.A definitive root cause for the set screws becoming torn cannot be positively determined.However, observed damaged suggests that the threads had become inadvertently cross threaded during insertion resulting in torn threads.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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