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Model Number 72203270 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during a hip arthroscopy procedure, the ball and socket joint on the hip distractor was not holding the foot in place and therefore the foot continuously slips out of place.Procedure was completed with the same device.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10: internal complaint reference: case (b)(4).H3, h6: ¿the reported device, used in treatment, was received for evaluation and forwarded to the supplier for additional investigation.There was a relationship found between the returned device and the reported incident.A visual inspection found no issues.A functional evaluation confirmed the boot pivot mount was not holding.A complaint history review concluded this was a repeat event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Based on the serial number of this device, the records show that it was manufactured from june 2015 to july 2015.The complaint was confirmed.The items identified as needing replacement or repair, have been determined to be from normal wear and tear that is the result of frequent use during this items service life.Factors that could have contributed to the reported event include repeat overtightening.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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