SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440366 |
Device Problems
Break (1069); Shipping Damage or Problem (1570)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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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 a genesis ii universal extractor broke in shipping.As this was noticed upon field inspection, there was no patient involvement.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection confirmed one end of the device is fractured, rendering it inoperative.A review of complaint history did not reveal similar events for the listed device.No adverse trend was found for this event.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 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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Search Alerts/Recalls
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