Catalog Number 03.501.080 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: at points during surgery, the application instrument would jam during tensioning, resulting in about five (5) minutes surgical delay.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Additional narrative: device was used for treatment, not diagnosis.Unknown patient information.Event date: unknown.Implant/explant date: unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ no ncrs 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 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.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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(b)(6).A product investigation evaluation was performed ¿ the complaint involve one (1) second generation instrument with the lot number 8623617.No components, screws or nuts are loose or missing on the returned device.In this non-manufacturing complaint investigation it was found that the trigger of the instrument, as per the complaint description, did not always function freely.However, after the instrument was lubricated as per the manufacturer¿s instructions, the function of the instrument was fully restored and three implants could be tensioned and cut as per the design intent.The cause of the functional issue is related to the not preformed lubrication of the device by the user.No design related issues could be identified by product development.The non-manufacturing complaint investigation of the second generation zipfix instrument is closed as determined as being invalid.Device is an instrument and is not implanted/explanted.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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