Catalog Number 03.605.002 |
Device Problems
Device Inoperable (1663); Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: june 12, 2014.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material, which was delivered as lot 27133839, is corresponding to the specifications.The hardness was measured at the time of the manufacturing between 46.10-48.93 hrc and was found to be good.No non-conformance reports were generated during production.Device 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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the screw from the upper shaft of a disc rongeur loosened and became lost, preventing the mechanism from working.The issue occurred during the cleaning process with no patient or surgical involvement.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis the subject device has been received and is currently in the evaluation process.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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Manufacturer Narrative
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A product investigation was completed: the investigation of the complaint rongeur has shown that the screw securing the upper slide is missing.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Unfortunately we are not able to determine the exact cause which has led to this occurrence.It is likely that too much mechanical force or a wrong handling has led to this damage.No product fault could be verified.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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Search Alerts/Recalls
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