Model Number Distal Femur Plate |
Device Problems
Failure To Adhere Or Bond (1031); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Examination of the involved plate revealed that the recess intended for handle connection was located with a 0.1 mm offset; this results in a difficult (although possible) plate-handle connection.Following investigation of the case, it was concluded that the reported case was a result of a manufacturing fault.This report is submitted following an fda inspection at the manufacturer facility.
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Event Description
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During operation, it was difficult to connect a piccolo composite distal femur plate and its handle (outside the patient body).Another plate was used.
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Search Alerts/Recalls
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