Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 1.5x4mm ht sd x-dr scr 5-pk cat#95-6104 lot#unk.Report source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00579.
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Event Description
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It was reported when used on the skull, the screw slipped.It would not turn properly.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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This follow-up report is being submitted to relay additional information.Two green anodized screws were returned.Visual examination of the returned product found that the screw slots are damaged and tips of screws had slight removal of green anodize from attempted use.As product is damaged dimensional analysis cannot be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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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