Catalog Number 254401017 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the handle broke while impacting femoral implant.No surgical delay.All pieces retrieved.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: conclusion and justification status: the complaint states it was reported that the handle broke while impacting femoral implant.The investigation confirmed that the lever had broken as reported.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure the complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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