Investigation summary visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03.010.072, lot number: l283434) was returned to cq west chester for investigation.The depth gauge was deformed close to the hook.No other issues were identified.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Measuring device used: ca122 (caliper).Complaint confirmed: complaint can be confirmed based on the available information.Conclusion: the depth gauge was found deformed near the hook during visual inspection.Hence, the complaint was confirmed, a definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot, part #: 03.010.072, synthes lot #: l283434, release to warehouse date: 12 may 2017.Manufactured by: (b)(4).No ncrs were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 as appropriate.
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It was reported that on october 19, 2021, three (3) depth gauges were found to be broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement and no additional information is available.This report is for one (1) depth gauge for locking screws to 100mm for im nails.This is report 2 of 3 for (b)(4).
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