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
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2020 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, surgeon noticed that the lock down portion of the instrument was not functioning properly and would not lock into place.Procedure was completed using a sn backup device.No delay was reported.The outcome of the patient in unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the short pointed floating spikes are severely damaged.There is also visible damage to the cam plate.All these issues would cause the stated failure.The device shows significant signs of wear/usage.The device was manufactured in 2004.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.
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Event Description
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It was reported that during surgery, surgeon noticed that the lock down portion of the instrument was not functioning properly and would not lock into place.Procedure was completed using a sn backup device.No delay was reported.The outcome of the procedure was good and no harm came to the patient.
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Search Alerts/Recalls
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