Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the black lever on the side of the hand piece that selects the graft thickness is loose according to the surgeon, therefore he was unable to get the thickness that he required.An alternate device was available for use.The event occurred during surgery.There was no reported patient harm, or delay.Due diligence is complete, and no further information is available at this time.
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone: (b)(6).G2: new zealand.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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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the reported issue could not be duplicated; however, the lever and ball plunger were replaced.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found 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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Event Description
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No additional event information.
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Search Alerts/Recalls
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