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Model Number SUTURE ANCHOR, HIP PUSHLOCK |
Device Problems
Break (1069); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2022 |
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 a hip arthroscopy with labral repair the tip of the anchor broke off while the surgeon tried to insert it.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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Manufacturer Narrative
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Complaint confirmed.Visual evaluation found that the eyelet is missing, and shaft of the device is bent.However, the 2.9mm pushlock eyelet was not returned for investigation.During insertion, excessive force may have caused the eyelet to break, and also bent the shaft.The observed condition is undetermined.
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Search Alerts/Recalls
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