SMITH & NEPHEW, INC. LGN RK HK OFFSET COUPLER TRIAL STD 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71431909 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference number: (b)(4).
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Event Description
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It was reported that, the spring of algn rk hk offset coupler trial std 4mm came out.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The spring on the device came out rendering the device inoperative.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.A historical review concluded that there are no prior escalated actions related to this part number and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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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