Catalog Number 03.501.080 |
Device Problems
Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2015 |
Event Type
malfunction
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Event Description
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Device report from synthes (b)(4) reports an event as follows: it was reported that a patient underwent a sternum closure procedure on (b)(6) 2015.During the operation, the handle to tighten the zipfix would not tension to the maximum amount.As a result, the surgeon had to tighten the zipfix ties manually.There was no reported time delay or patient harm.This report is 7 of 8 for (b)(4).
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Manufacturer Narrative
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Additional narrative: patient information is not available for reporting.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)(4).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing site: (b)(4) - manufacturing date: august 27, 2013 no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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Manufacturer Narrative
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Additional narrative: subject device received; no conclusions could be drawn as the device is entering the complaint system.Device is 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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Manufacturer Narrative
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A product development evaluation was completed: the internal moving components of the returned second generation zipfix instrument showing only a few marks and scratches, which indicates a short time clinical use.No instrument screws are missing or loose.No damages or functional issues were identified.The performed handling test by product development with the returned instrument and 3 implants on a sternum bone model showed no functional deficiencies in tensioning and/or cutting the implants with the instrument.The tension applied is as per the design intent.There is no functional or design related issues identified on the returned instrument.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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