Model Number UNIVERS REVERS HUMERAL LINER IMPACTOR |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder prosthesis surgery the white cap of the device was defect.The thread couldn`t be screwed.No part of the device broke off.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 28-mar-2022: it was confirmed that the white cap of the device broke.
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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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Manufacturer Narrative
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Complaint confirmed.Upon visual inspection it was found that the insert is missing.The cause of this event remains undetermined.
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Search Alerts/Recalls
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