Model Number N/A |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that when the surgeon was preparing the tibia, the cementless keel saw blade snapped off in the bone.The hall power tool reciprocating attachment loosened from the hand piece and the saw blade twisted out.The event occurred during surgery.There were no adverse effects for patient apart from time wasted.There was a five-minute delay to get another pack of blades to complete the procedure.No additional medical intervention was required.Due diligence is complete and there is no further information available.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under cmp(b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Initial reporter: telephone: (b)(6).Report source: foreign: new zealand.
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Event Description
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There is no additional information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual examination of the provided picture identified that the cementless keel saw blade head had broken off.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned.
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Search Alerts/Recalls
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