Catalog Number 254500941 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device confirms the reported event of trial damage.The observed cracking is initiating around the metal insert of the trial.A pra (b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of australia concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned device.Based on the performed investigation and pra (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via sep-419.
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Event Description
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It was reported that instruments were broken.Didn't impact any case.
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Manufacturer Narrative
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(b)(4).Investigation summary examination of the returned device confirms the reported event of trial damage.The observed cracking is initiating around the metal insert of the trial.A pra(b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of australia concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned device.Based on the performed investigation and pra(b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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