Model Number N/A |
Device Problems
Break (1069); Nonstandard Device (1420)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).Recall zfa2018-00369 was performed on the affected item.This item was not delivered to the usa.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the instrument broke at the level of the sealed part.The instrument has been used 3 times since its launch.The material was used according to the surgical technique and the contact said that there was no impact for the implant of the patient.No adverse patient consequence was reported.
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Event Description
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It has been reported that the instrument broke at the level of the sealed part.The instrument has been used 3 times since its launch.The material was used according to the surgical technique and the contact said that there was no impact for the implant of the patient.No adverse patient consequence was reported.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Products were returned to zimmer biomet and the breakage on the avantage thread shaft straight was confirmed by research and development.The root cause was assessed as related to the device design.A corrective action was initiated on the avantage thread shaft straight to investigate and take appropriate actions.Moreover, a recall was performed on avantage thread shaft straight, reference (b)(4).Please note that no device in the scope of the recall had been distributed to the usa.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Search Alerts/Recalls
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