Model Number BASEPLATE IMPACTOR, ASSEMBLY |
Device Problems
Break (1069); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the blue attachment is defective, it broke off during shoulder prothesis surgery.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
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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.One unpackaged ar-9165cdg was received for investigation.Visual inspection identified that the post across the face of the baseplate had partially broken.No fragments were returned for inspection.A probable cause is attributed to damage incurred during the removal process.
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Search Alerts/Recalls
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