Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 10/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.This device is not distributed or manufactured in the united states; however, this report is being filed as zimmer biomet in (b)(4) manufactures a similar device under 510k number k982545.This report is number 2 of 2 mdrs filed for the same event (reference 3006946279-2016-00432 / 00433).Both products were used during the procedure and it is unknown which device fractured.
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Event Description
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During a revision surgery of a left hip prosthesis, the cable fractured during the cable tension adjustment.There was no patient injury or delay.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Udi (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Evaluation of the returned devices found the 2 cables was not broken.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to over-tensioning.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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