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Model Number N/A |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling,¿ and ¿inspect the instrument case and instruments for damage upon receipt and after each use and cleaning.¿ this report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2016-04006 / 04008).
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Event Description
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It was discovered during kit inspection that the color plug pin is beginning to separate from the spherical mill.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling,¿ and ¿inspect the instrument case and instruments for damage upon receipt and after each use and cleaning.¿ 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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