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Model Number 71867066 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a trauma surgery while the instrument was inside of the patient, the screw was not locked and penetrated the hole on the plate.The peri-loc 4.5mm ti l-d fem pl 8h l 193mm, peri-loc 4.5mm t25 ti lck scr 66mm s-t, two (2) peri-loc 4.5mm t25 ti lck scr 64mm s-t and peri-loc 4.5mm t25 ti lck scr 58mm s-t; it was unknown if the plate or which screws reported were defective.The procedure was successfully completed putting back and rotating in an opposite direction without delay using the same device.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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