Initial reporter contacted vilex on december 8, 2022 to report the malfunction of the methead driver.One of the pins on the driver broke during the insertion of the implant.The pin remained in the implant with no protrusions and was unable to be removed.The incident happened towards the end of the surgery with the implant already fully seated.Surgeon decided to complete the surgery.No delay in surgery occurred.The reusable instrument was returned to vilex and examined by vilex quality control.Signs of damage were noticeable on the remaining pin of the instrument.No indication of misuse was found.All product dhrs were reviewed and no deviations were found relevant to the incident that occurred.No other quality records were found to be associated with the device.Due to the nature of the reusability of the device, probable root causes of the malfunction are excessive force during insertion or degradation after multiple uses over the course of 10+ years of field distribution.Should more information become available, vilex will file a supplemental report.
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