Catalog Number 18061401 |
Device Problems
Device Operates Differently Than Expected (2913); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that while trailing the instrumentation with sawbones, the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threadings.Due to these circumstances the instrumentation would not function properly in a live case.
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Manufacturer Narrative
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The evaluation revealed both instruments to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The instruments were documented as faultless prior to distribution.An investigation was not possible because the instruments were not provided.The root cause could not be determined.The customer reported that the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threading¿s.Most likely the nail adapter connection profile was deformed (user related); in that case an attachment of the nail and nail holding screw (nhs) is no longer possible.If fretting of the nhs occurred within the nail adapter could not be excluded.(b)(4) was initiated, resulting in a 100% inspection, implemented in august 2013.Both instruments were manufactured to a time where the action was already in place.A more precise evaluation was not possible based on the given information.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
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Event Description
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It was reported that while trailing the instrumentation with sawbones, the nail adapter would not properly seat into the fittings on the nail, and the nail holding screw would not engage properly into the nail threadings.Due to these circumstances the instrumentation would not function properly in a live case.
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Search Alerts/Recalls
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