Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products : 231200200, 320679, drill bit 2.2mm ns, 131822040 dvr lock mini l.Foreign country: (b)(6).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 has been reported when the cortex was drilled out using the fast guide; the drill fractured off and got stuck.The surgical technique was followed.The bone structure or cortex was normal.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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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.The following sections were updated/corrected.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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