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Model Number 71631140 |
Device Problems
Fracture (1260); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2022 |
Event Type
Injury
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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 a trauma surgery, at the moment of removing the clove from the arch, using the guide bolt wrench device, the screw did not come out of the clove after many attempts, the screwdriver broke inside the clove.The screws were removed from the patient's clove and after an hour of trying, it was possible to unscrew it and the new clove was placed.The procedure was resumed, after a significant delay, with a competitor device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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D4: lot# and expiration date, h4: device manufacture date.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip of the device broke off, rendering the device inoperable.The broken piece was returned.The device exhibits signs of significant use and wear.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the instructions for use file is not applicable for this instrument.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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.H6: health effect - impact code.
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Search Alerts/Recalls
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