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Model Number 72412418 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during an internal fixation surgery an evos 2.4mm x 18mm lck scr t7 s-t did not lock into the evos volar plate 3h r std 48mm.Surgery was completed, without any delay, with a sn back-up device.No harm to the patient or further complications reported.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is stripped rendering the device inoperative.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to surgical technique used, procedural variance, fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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