Catalog Number 13200100 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/15/2014 |
Event Type
malfunction
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Event Description
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It is reported by the surgeon, that misdrilling occured.
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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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Manufacturer Narrative
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Appearance of item and inspection records identified the target device returned being of new design version.Deviations in the inspection documents were not found.A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery.The item returned was documented as faultless prior to distribution and as it had been in use for a longer time (approximately 4 years) we pre-suppose that this target device had fulfilled its tasks in former surgeries as intended.The returned target device passed the pre-operative function test as intended.Neither a proximal mistargeting nor a distal mistargeting could be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event(s) were mainly based in the intra-operative procedure.Referring to received information it is suggested that potential deviation in proximal targeting accuracy should have been detected during required functional check prior to use.No information was given which kind of nail had been used.Further, the kind of preparing the intramedullary canal may be essential for inserting the nail without deflection.Depending on the bone curvature this may contribute to sufficient drilling.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure.
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Event Description
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It is reported by the surgeon, that misdrilling occured.
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Search Alerts/Recalls
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