Model Number N/A |
Device Problem
Misassembled During Installation (4049)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: patella reamer surfacing guide, catalog number: 00512007141, lot number: unknown.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 during a knee arthroplasty, the instrument would not assemble to the reamer guide.Subsequently, another instrument was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
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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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This follow-up report is being submitted to relay additional information. complaint sample was evaluated and the reported event was not confirmed.Device history record was reviewed and no discrepancies were found.Visual examination of the returned device indicates that the device exhibits signs of use (surface scratches).Dimensional examination indicates that the device conforms to the measurable print specifications.The device passed the functional check.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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