Catalog Number 399.480 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/30/2014 |
Event Type
malfunction
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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 a tip of a rasp broke off, there was no reported patient involvement, no reported surgery.The device was found in the sterile processing department, no other information was provided.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was received.A review of the device history records was performed and no complaint related issues were found.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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Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.An evaluation was performed on the returned device.As per received condition the device had a broken and missing tip.The broken surface is homogenous, that indicates good material consistency.During the device history record review it was found that the complained device was manufactured according to the specifications.The lot was produced in 2012.Since the broken tip is missing and no further information was provided, an exact root cause could not be determined.Excessive force may have led to the breakage.No product fault could be detected.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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