SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71441144 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
malfunction
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Event Description
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It was reported that, a gii mis dcf align gde ((b)(4)) had a bent pin, and a gii mis dcf align gde ((b)(4)) had an ineffective cam lock.It is unknown if the event happened during surgery or if there was any delay nor injury reported.It is unknown if there was a s&n backup device available.
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Manufacturer Narrative
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H6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of extensive use.A functional evaluation was performed on the device and confirmed the stated failure mode.The locking mechanism of the returned device will no longer lock securely rendering the device inoperable.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.
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Event Description
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It was reported that a gii mis dcf align gde had an ineffective cam lock.The procedure was able to be completed with the same device.Surgery was not delayed.As this was noticed after surgery, the patient was no longer involved.
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