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Catalog Number 71340007 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
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, while tightening, the clamp of an acc 2.0mm cocr cable w/clamp broke.No pieces fell inside the wound.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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The device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of wrought cobalt-chromium-molybdenum alloy shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.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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