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Catalog Number 71674076 |
Device Problems
Break (1069); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during surgery, the t-handle broke and did not attach properly.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Manufacturer Narrative
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Results of investigation: the associated device was returned and evaluated.A visual inspection of the device was conducted and confirmed the device is excessively worn, which could cause it to not function properly.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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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