Catalog Number 112290 |
Device Problems
Mechanical Problem (1384); Misassembly by Users (3133)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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After surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Case type: tka.Patient was under anesthesia.
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Manufacturer Narrative
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It was reported that "after surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Patient was under anesthesia." the event was confirmed.Method & results: device evaluation and results: visual inspection: the adapter showed signs of damage.Functional inspection: the device is non-functional.Product history review: review of the device history records indicates 200 device(s) were manufactured and accepted into final stock on 09oct2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112240, lot 19030517 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the investigation concluded that alleged failure mode was caused by damage.
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Event Description
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After surgery was completed, taking apart the femoral array the scrub tech and i noticed the array adapter and femoral array were cross-threaded.Case type: tka.Patient was under anesthesia.
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Search Alerts/Recalls
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