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Model Number N/A |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Mini ratchet handle ao, cat#:110017406 lot#: ni , hdls cmpn scr 2.5x22 ns, cat#:110018421 lot#: ni.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 during a scarf osteotomy to fix a hallux valgus, while seating the headless compression screw, the tip of the driver bent.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Reported event was confirmed by review of provided photographs.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to plastic deformation as a result of the design of the device.These drivers have been designed to twist before fracture of the screw.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.Product location unknown.
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Search Alerts/Recalls
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