ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 110024773 |
Device Problems
Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that the anchor did not deploy and the device trigger stuck during a procedure.No harm or impact to the patient was reported.Attempts have been made and no additional information on the reported event is available at this time.
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Manufacturer Narrative
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(b)(4).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.Zimmer biomet will continue to monitor for trends.Associated products: item#110024773; lot#65867330.Item#110024773; lot#65867330.Item#110024773; lot#035060.
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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 no etching on the device and no packaging returned.Both anchors remain in the needle and the device was cycled one time.After performing a function check by cycling the push button one time, both anchors came out of the needle.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Anchor deployment issue: a definitive root cause cannot be determined.Button advancement issue: upon conclusion of the investigation, no problem was found with the given device as the push button was function tested determining to not be stuck; therefore, it functioned as intended.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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Search Alerts/Recalls
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