Model Number N/A |
Device Problems
Fracture (1260); Material Twisted/Bent (2981)
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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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Manufacturer Narrative
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(b)(4).G2: foreign ¿ canada.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the tip of the depth gauge was bent and when trying to straighten on the table, it broke.A back-up device was available to complete the surgery.There was no known impact or consequences to the patient.It was reported that no further information is available.
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Event Description
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No further information is available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the tip of the gage to have fractured at the distal most measuring notch.The tip was not returned.The handle exhibits scuffing, scratches, and dings.It is unknown when or how the tip was initially bent.Complaint confirmed based on the evaluation of the returned product.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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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