ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 110024773 |
Device Problems
Fracture (1260); Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the green handle of the device fractured during use.It was noted that the black button was hard to be pushed forward compared to how it normally is, so the anchor was difficult to deploy.There was a small delay in order to prepare a backup to complete the surgery, but no patient consequences or harm were reported as a result of the event.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).E1: full establishment name - (b)(6) hospital.G2: foreign - event occurred in japan.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.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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