Catalog Number 110029136 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Common device name: phx.Concomitant medical devices: compr rvs bsplt rmr 25mm short cat# 110029136 lot# 482230; compr rvs bsplt rmr 25mm short cat# 110029136 lot# 379770.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00009, 0001825034 - 2021 - 00011.
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Event Description
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It was reported that the reamers are dull and need to be replaced.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected:
b4, b5, g3, g6, h2, h10
upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.
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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 the reported event.The initial report was submitted in error and should be voided.
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Search Alerts/Recalls
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