Catalog Number UNK_KIE |
Device Problems
Failure to Align (2522); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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The customer reported that the gamma nail broke and was revised.During the revision case, the customer had significant difficulty noisy drilling for the lag screw.The new lag screw was too short and they changed the length.However, upon removing the new shorter lag screw they realized it was badly scored.The surgeons feel that the jig isn¿t accurate.
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Manufacturer Narrative
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Correction: refer to d10/h3 device availability, h6 device code.The reported event, instrument ¿ mis-drilling, was not confirmed.Review of complaint history, labelling and capa databases could not be performed since no catalog and / or lot number was communicated.The risk analysis did not identify any discrepancies more detailed information about the complaint event such as the surgeon¿s pre-operative tests or why he did not stop drilling when he realized ¿noisy drilling¿ must be available in order to determine the root cause of the complaint event.Pre-operative functional testing is required in the labelling.Potential misalignment causing mis-drilling with damage of implants can easily be detected during required functional check prior to use.The root cause for alleged mis-drilling could not be determined.In case the instrument and / or other essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.H3 other text : device disposition is unknown.
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Event Description
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The customer reported that the gamma nail broke and was revised.During the revision case, the customer had significant difficulty noisy drilling for the lag screw.The new lag screw was too short and they changed the length.However, upon removing the new shorter lag screw they realized it was badly scored.The surgeons feel that the jig isn¿t accurate.
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Search Alerts/Recalls
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