Catalog Number 329.400 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported, that the bending plate broke intra-operatively during modeling during an initial procedure.No prolongation of the surgery was reported.No fragments were generated and the procedure was successfully completed.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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(b)(4).On feb 13, 2017, (b)(4) was created in order to separate the malfunctions of the devices into two complaint due to one event occurring post-op ((b)(4)) and the event occurring during the revision ((b)(4)).This event/ part# is captured and reported under (b)(4).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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