SMITH & NEPHEW, INC. SEMIEXTENDED GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71654525 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during trauma surgery, the semiextended guide bolt was fixed in the nail through the guide but when it should be removed, it was stocked in the nail and there was no possibility to remove it.The threaded proximal part in the nail did look good so no harm was caused.A smith and nephew back up device was available.No injury to the patient.A significant delay was reported.
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Manufacturer Narrative
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Internal complaint reference: (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 returned device did not confirm the stated failure.There is no nail stuck inside the guide bolt.The visual did confirm some damage to the threaded portion of the device.The device shows signs of normal wear and use.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.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.A contribution of the device to the reported event could not be corroborated.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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