ZIMMER BIOMET, INC. JUGGERKNOT 1.4MM SHRT W/NDLS; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES
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Model Number 912068 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that while being used by the surgeon the instrument was bent and the implant could not be inserted.A second instrument was used and the surgeon was unable to insert the instrument.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02237.Medical products: item#: 912073, jgrknt 1.4mm short disp set; lot#: 662470, item#: 912068, juggerknot 1.4mm shrt w/ndls; lot#: 0002315196.Reporting source: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr 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 information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02237-1.Visual evaluation of the returned product identified the tip of the inserter bent and fractured with not all the pieces being returned.The anchor and suture lines are detached from the needle tip.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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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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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