Model Number N/A |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Code Available (3191)
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Event Date 02/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been returned for evaluation at the time of this reporting.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported that hole 1 was bypassed too far laterally, causing the need for a longer incision.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.The product was not returned, and its location is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Manufacturer Narrative
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This follow up report is being submitted to report additional information.
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Search Alerts/Recalls
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