Model Number N/A |
Device Problems
Fracture (1260); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2023 |
Event Type
Injury
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Event Description
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It was reported that the instrument fractured during operation and piece of impaction head got stuck inside the jig.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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Manufacturer Narrative
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(b)(4).G2: foreign: south africa.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 report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Proposed annex g code: mechanical (g04) - impactor; visual examination of the provided pictures identified that the distal end of the impaction head had broken off in the targeting guide.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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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.Visual examination of the returned product/provided pictures identified a znn impaction head was returned for evaluation.As returned, the threaded feature is fractured and missing.The device exhibits wear & tear that indicates repeated use.The features of the fracture surface visually align with a rotational fatigue culminating in tensile overload fracture failure mode was identified.The reported event is confirmed by returned product.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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