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 07/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that a frame pin fractured while assembling.This occurred before surgery and there was no patient involvement.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 report is being submitted to relay additional information.Visual examination of the provided picture identified the rounded tip of the instrument has broken off and is not shown in the picture.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.A definitive root cause cannot be determined.This complaint was confirmed based on the provided picture.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 information at the time of this report.
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Search Alerts/Recalls
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