Model Number N/A |
Device Problems
Fracture (1260); Difficult to Advance (2920)
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Patient Problems
Necrosis (1971); Device Embedded In Tissue or Plaque (3165)
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Event Date 04/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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It was reported that during a trauma procedure, while trying to reduce and stabilize the fracture, the kirschner wire was not able to pierce the bone, which resulted in overheating with necrosis of the tissue.The wire eventually fractured while inside the patient.All of the fractured product was removed from the patient.The procedure was successfully finished with different zimmer biomet wires.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Corrected event date is unknown 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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