SMITH & NEPHEW, INC. SUBTROC LAG SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71674068 |
Device Problems
Break (1069); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
Event Type
Injury
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Event Description
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It was reported that, during nail extraction, the threads on the lag screw retaining rod ((b)(4)) sheered off inside the intertan lag screw ((b)(4)) while inside the patient.The procedure was finished with a smith and nephew back up device without delays.The patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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 have no 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely 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.Without the return of the actual product involved or product information, our investigation could not proceed.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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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threaded tip of the device was fractured, rendering the device inoperative.The fractured component was not returned.The lag screw driver was also not returned.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.A review of the risk management file revealed this failure mode was previously identified.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.
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Search Alerts/Recalls
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