Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 08/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Customer indicated that device will be returned for evaluation.Once device is received and evaluated, a follow up report will be submitted to relay any additional information.
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Event Description
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It was reported that device fractured during surgery and remained in patient.Significant surgical delay was reported for this event.No other patient harm was reported for this event.
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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.G3: foreign: event occurred in malaysia.The investigation is still in progress.Once the investigation has been completed, a follow-up mdr will be submitted.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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Manufacturer Narrative
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Quattro suture passer needle was received and evaluated against the complaint.Product returned with obvious signs of damage.The suture passer needle is bent and fractured at the tip.Operative notes were not provided.An xray was provided and reviewed by a health care professional.A small curvilinear foreign body was identified in the subacromial space of the right shoulder during arthroscopy.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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