Catalog Number 273340107 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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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Event Description
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Libertas: it was reported that on (b)(6) 2019, the 6mm dual-lead tap was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.
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Manufacturer Narrative
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Product complaint # (b)(4).Udi: (b)(4).H3: correction.H6: additional information.Visual inspection of the returned device found the handle had a vertical crack.The crack was proximal the end portion of the dowel pin.The instrument/handle was separated into three pieces.No other issues were identified with the returned components of the device.No product design issues or discrepancies were observed during this investigation.A cursory inspection of the complaint file for the reusable device that was found damaged does not point to a manufacturing issue.Therefore a device history review is not required.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
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Search Alerts/Recalls
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