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 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the procedure, the spring that is hooked to the claw on the tip of the remover was broken.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).G2 - foreign: japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and corrected information.D2 - device product code was corrected.Visual examination of the returned product confirmed that the item and lot information match that which is listed in the complaint.The device shows signs of use with galling on the shaft of the trial remover.The tension spring that is between the two clamps has fractured and not all the pieces were returned.The clamps now open and close freely without tension.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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