This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned without packaging.The instrument was visually evaluated and found to have a section of the depth gauge spike broken off.When the spike is slid, the remaining portion of the spike begins to exit the guide at 18 mm, indicating the section of the tip broken off was roughly 18 mm in length.The instrument is in good overall cosmetic condition with scratches and normal signs of wear from use; slight discoloration was observed on the handle and the interface between the spike and slide.The manufacturing history was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to excessive force applied by the user.The spike is delicate as the tip tapers from.034¿ to.022¿ thick.A summary of the investigation will be sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Based on the product evaluation, the following fields were updated: report date to reflect the date of this report.Date received by mfr to reflect the date the product evaluation as completed.Type of reports to reflect this is follow up report #1.If follow-up, what type? to reflect the reason for the follow-up report.Device evaluated by mfr? to reflect the product evaluation is completed.(b)(4).Additional mfr narrative to reflect relevant additional information.
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