Catalog Number 6541-2-609 |
Device Problems
Break (1069); Fracture (1260); Material Integrity Problem (2978)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2015 |
Event Type
malfunction
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Event Description
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When the device was being removed from the patient, the ankle clamp broke.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding a fractured triathlon tibial alignment ankle clamp was reported.The event was confirmed.Method & results: devaluation and results: visual analysis confirmed the reported event.One of the device flippers fractured.The device was manufactured to the g revision medical records received and evaluation: not performed because there is no indication the event was related to patient factors device history review: review of the device history records indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been other similar reported event for this lot id.Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use.Ncr and capa were opened to perform a root cause investigation.Capa was closed on 10-mar-14.
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Event Description
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When the device was being removed from the patient, the ankle clamp broke.
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Search Alerts/Recalls
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