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Model Number TIGHTROPE ABS BUTTON ROUND 20MM CONCAVE |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
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 anterior cruciate ligament surgery when the surgeon stretched the implant ar-1588rtt during the surgery as a technique, without applying additional force the implant ar-1588rtt broke and the surgery with this implant could no longer be continued.The broken pieces were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device from a different manufacturer.It was not necessary to switch the surgical technique or do a second surgery.Because the implant was in contact with the patient, it was discarded during surgery.
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Search Alerts/Recalls
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