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 11/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
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Event Description
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A patient was undergoing a surgery due to a peri-trochanteric fracture.The pin of the ancillary broke in the patient body.Despite multiple tries to remove the piece, it remains in the body.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.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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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.A threaded pin was returned to the product surveillance team for evaluation.Visual examination of the returned product identified the item fractured at the junction of the threaded portion; the threaded tip was not returned.The device hardness was performed and found to be within the print specifications.Device was submitted for further analysis.Analysis determined threaded pin fracture surface showed suspected crack initiation and exit areas and indications of a torsional overload fracture.The eds quantitative analysis of the pin showed it was consistent with 316 stainless steel.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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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