Model Number N/A |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05603 and 0001822565-2019-05330.Product has been received by zimmer biomet and 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 during a knee procedure, a drill pin was cross-threaded in a cut guide and became stuck.It could not be removed from the cutting block.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 confirmed.Visual examination of the returned tibial cut guide found signs of repeated use (nicked/ gouged) and burrs and an unknown pin is jammed in the guide.Device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the returned device indicates heavy usage, however as the number of times the device has been used is unknown, a definitive root cause cannot 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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