SYNTHES GMBH TI END CAP FOR TFNA 5MM EXTN - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.038.005S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is an unknown date in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that during a procedure, the trochanteric fixation nail advanced (tfna) end cap 5mm did not fully insert, but the 0mm did.This report is for a titanium (ti) end cap for tfna 5mm.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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