Model Number IIPDTUL |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint number: (b)(4).
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Event Description
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It was reported that the universal ratchet extension implant driver is getting stuck in the implant.
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Manufacturer Narrative
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Zimmerbiomet complaint number (b)(4).The following sections have been updated: d1: brand name.D4: catalog and lot number.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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Zimmerbiomet complaint number (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.Complainant reported that it was reported that the universal ratchet extension implant driver is getting stuck in the implant.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.The following sections have been updated: d4: expiration date, udi h3: device evaluated by manufacturer: change ¿no' to 'yes' h4: device manufacture date h6: evaluation codes h10: additional narrative.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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