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Model Number CNULA.SCRW,STRL PT THD 3.75X38MM |
Device Problems
Break (1069); Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint confirmed.One unpackaged ar-7000-38s (no batch number provided) was received for investigation.Visual inspection identified breakage at the distal end of the returned ar-7000-38s.It was determined that approximately 1.4955" of the screw was returned.The screw diameter was assessed and was found to meet design specifications.The method used to prepare the joint during the procedure, as well as the bone quality encountered, was not provided.The cause remains undetermined, although a probable cause can be attributed to improper bone preparation.
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Event Description
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It was reported that during gleno-ac-joint surgery, the screw was delaminated during the procedure.The broken off piece has been retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device, 10304992.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 21-sep-2021.Received further information that the screw was broken.
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Search Alerts/Recalls
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