As reported: "there were problems with insertion when the tibial nail was driven in.Impact dome and nail pick-up presumably defective.Item is 10 years old.Item has been re-processed 100 times." 10/5/2021: additional information received: nail was successful inserted, but the surgeon want to be sure, that the upcoming cases are save ( the nail adapter is correct ).That¿s why they wanted to check the nail adapter.The strike plate was damaged by them.The patient has no damage or consequences.At least the strike plate is more than 10 years old and it was for instance too much power.
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The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail handle and strike plate presents significant impact marks.The devices were manufactured in 2004, so it can be said that they have performed their function in the previous surgeries as intended without any reported failure.Since they have been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.The fatigue of the material under bending stresses could have induced pre-damage to the material which would have finally gave in because of torsional overload.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿do not hit instruments unless they are specifically intended for impaction.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.The device was manufactured in 2004, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since they have been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.
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