Model Number N/A |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 that the mini baseplate inserter fractured during an initial shoulder arthroplasty.No patient harm was reported.Attempts have been made and no additional information is available at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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Complaint sample was returned and evaluated against the reported event.Visual examination of the returned product identified the part to have strike marks, heavy scratches, dings and gouges.It is confirmed that the part is broken and not fractured.The receiving end of the threads are damaged causing the strike plate to be screwed in incorrectly.Visual inspection of the returned product to verify item number.The lot number is etched on the part but the area where it is etched has been damaged making it illegible to read.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause of the reported issue is attributed to user error, the product is cross threaded which can only happen if it has been disassembled and this device is not to be disassembled.A summary of the investigation findings were sent to the customer.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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Manufacturer Narrative
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(b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute to a sentinel event.
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Event Description
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to a sentinel event.
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Search Alerts/Recalls
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