Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Event Description
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It was reported the pin screw driver broke during pin insertion.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Product has been returned to 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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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.The results of the investigation are as follows: visual examination of the returned products identified signs of repeated use.The tip of the driver was fractured.The potential field age of the instrument was 7 years.Dimensional analysis were performed and it was conforming where it measured.A review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to repeated use of the device for more than 7 years.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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