Model Number N/A |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr's were filed in association with this reporting: 0001825034-2019-05457.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.The physician still uses the device.
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Event Description
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It was reported the surgeon has inadvertently chipped off chunks of the patient glenoid while reaming due to the inability to clearly visualize the glenoid.The surgeon admittedly uses the reamer off-label.No further information is available at the time of this reporting.
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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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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.As per the complaint info, it was identified the root cause of the reported issue is attributed to user error due to incorrect usage of the device.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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