Model Number N/A |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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Pt identifier: - (b)(6).Device product code - kdd.Udi number - (b)(4).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.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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It has been reported that during an acl reconstruction procedure, metal shavings were noticed in the knee joint after using the 2.4mm drill tip pin from the kit.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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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It has been reported that during an acl reconstruction procedure, metal shavings were noticed in the knee joint after using the 2.4mm drill tip pin from the kit.It is unknown if all metal shavings were successfully removed.
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Manufacturer Narrative
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The complaint sample was evaluated, but the reported event could not be confirmed.The device history records were reviewed and no deviations relevant to the reported event were identified.A complaint history search was performed and no actions are required.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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Search Alerts/Recalls
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