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Model Number DRIVER, T10 HEXALOBE |
Device Problems
Break (1069); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during an ankle joint surgery the device twisted.A part of the device broke off inside the patient, but all fragments were retrieved.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update 21-jun-2022 it was confirmed that no part of the device broke off and remained inside the patient.During unscrewing, too much force was used.Therefore the defect occurred.
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Manufacturer Narrative
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Complaint confirmed.One unpackaged ar-8944dh driver was received for investigation.Visual inspection identified that the drive geometry at the distal tip of the returned ar-8944dh was chipped and twisted.A likely cause is attributed to over-torquing/over-engaging the driver within the screw head.
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Search Alerts/Recalls
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