STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 3125-0170S |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported; "the target device and the holding screw were stuck and could not be removed from the nail after the nail insertion.After that, other instruments and nail were used and the surgery was finished." time extension of about 20 minutes.
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Manufacturer Narrative
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The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the received device came back jammed/assembled which was unblocked by holding in wise after that there were no visible damages, but a huge amount of dry blood was observed which could be a reason for the jam issue.After the decontamination, the functional test was performed by assembling and disassembling the device in which there was no issue observed just the chunks of dried blood/substance fell off.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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As reported; "the target device and the holding screw were stuck and could not be removed from the nail after the nail insertion.After that, other instruments and nail were used and the surgery was finished." time extension of about 20 minutes.
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Search Alerts/Recalls
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