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Model Number 71070710 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
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, the shoulder bolts of a fast fx strut for tsf med and fast fx strut for tsf sht were tightened by hand and could then only be released with a wrench.Both threads were broken as a result.The shoulder bolt on the fast fx strut for tsf med even broke off.It is unknown whether the event happened during surgery and if there was patient involvement.
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Manufacturer Narrative
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(b)(4).Correction made to the event description.
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Event Description
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It was reported that, during an external fixation, the shoulder bolts of a fast fx strut for tsf med and fast fx strut for tsf sht were tightened by hand and could then only be released with a wrench.Both threads were broken as a result.The shoulder bolt on the fast fx strut for tsf med even broke off.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
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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 returned device confirmed the stated failure mode.The device's thread components were damaged which prevented the device from tightening again.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The manufacturing process of the device did not contribute to the reported event.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.Some potential probable causes could be but are not limited to user error or excessive loading on device.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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