Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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During a hip revision of non zimmer biomet products, the tip of the arcos screwdriver broke when screwing the trial cone body on the stem implant.No pieces fell into patient.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 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.The event was confirmed with product received.Upon visual inspection the body shows scuffing around the screw location.The driver had fractured at the tip and shows a dark line around the shaft near the fracture site.Xrf analysis found the hex driver material to be consistent with 430/440 stainless steel alloy.The features of this fracture surface align with torsional overload.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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