Model Number N/A |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Information (3190)
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Event Date 09/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional concomitant medical products: arcos 16 x 200mm stem trl, pn 31-301616, ln 7851206.(b)(6).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09350.Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.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 an instrument was unable to disconnect broach body from the trial stem.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Event Description
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No further event information available at the time of this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Udi number - (b)(4).Concomitant medical products : arcos stem trl, catalog #: 31-301616 lot #: 7851208.Reported event was confirmed by review of visual inspection of the devices identified the two parts were stuck together.The body broach has impact damages likely caused while trying to remove the broach from the stem.The distal portion of the trial stem has impact damages and likely caused the stem to stuck inside the broach.The screw that locked the broach and trial was able to be unlocked and locked into position.However, with the screw in the fully removed position, the broach was unable to be separated from the stem without the possibility of damaging either part.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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