Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Report source: foreign country - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported during a trauma case where the patient had massive facial injuries the screw driver blades were not picking up or retaining the screws.The blades were worn out and were not picking up the screws or the screws would fall off the blade into the wound.Removal of the fallen screws can be challenging when working through small openings and it can be extremely difficult to retrieve the fallen screws.The surgeon called the sales representative during the case to request he urgently bring new blades.The duration of the surgical delay is unknown.No additional patient consequences were reported.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Functional testing and inspection of the blades and screws could not be performed because they were not returned.Three attempts were made for additional information and product return with no new information yielded including the part number of the screws.Device history record (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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Search Alerts/Recalls
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