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Catalog Number 6901189 |
Device Problems
Failure to Align (2522); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2018 |
Event Type
malfunction
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Event Description
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It was reported that during acl procedure, all devices were assembled.When a guide wire pass through, using a bullet, the tips of guide wire and aimer were misaligned.It seems that tip of aimer deformed.The procedure was completed with the same device.60 minutes delay was reported.There was not patient injury, harm or complications during or after the procedure.
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Manufacturer Narrative
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One 6901189 lateral entry anterior femoral acl aimer returned.This is identified as a ¿made to order, special order¿ item.The complaint stated: ¿all devices were assembled.When a guide wire pass through, using a bullet, the tips of guide wire and aimer were misaligned.It seems that tip of aimer deformed.¿ mating parts 7205517/50745756, 7205519/50742223, 7205524/50708480, 7205525/50711223 were not returned.As the original mating components were not returned, the source of the mismatch was visually confirmed.The tip of device is not completely plane.S+n is aware of the potential offset.Dimensional and functional evaluation of this system has been performed by engineering.A process improvement is underway to improve the manufacturing process which includes an additional flatness check on the aimer with the goal to improve and align knee arthroscopy drill guide aimer family final inspection processes to adequately control alignment between the guide wire and the target on the aimer.Ensure controls are aligned with the refurbishing department.No further investigation is warranted at this time.
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Search Alerts/Recalls
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