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Model Number 72201725 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that during a hip arthroscopy, the strap which secures the foot into the active heel traction boot broke since it was routinely over tighten.Since there was not any back-up device available, it is unknown how the procedure was completed; nevertheless, the procedure was not delayed 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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H11.Correction in d1, d2 and d4.
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Manufacturer Narrative
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H3,h6: the device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A dhr review was not performed because the serial number was not provided.A complaint history review found other related failures.Factors that are known to contribute to the alleged fault/failure may include worn straps or a defective buckle.If the product is returned in the future the complaint can be reopened and evaluated.This failure mode will be trended to assess for any necessary corrective actions.No further investigation is required.
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Search Alerts/Recalls
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