ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 110024773 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the anchor would not deploy.It was noted by the surgeon that the threads appeared to be tangled inside of the device.The surgery was successfully completed with a second device.No patient consequences 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).G2: foreign - event occurred in japan; customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.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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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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.If any further information 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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