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Model Number P40-002-0275-S |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device history record was reviewed and met all material specifications with no deviation identified.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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Event Description
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It was reported that the patient underwent a surgical procedure that utilized paragon 28 hammertube system.The 2.75mm, 10 degrees cannulated hammertube implant was reported broken during reduction.It was reported that the implant remained in place and a k-wire was used to stabilize the area.A revision surgery was not reported.
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Search Alerts/Recalls
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