It was reported that the hip distractor was not tightening on the boot holder clamp.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The reported device, intended for use 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.The product evaluation confirmed the reported failure.The knob spacer, thrust pivot, handle lock, ball joint lock tube, spherical distractor mount, bellows, barrel nut, mast end cap and clamp bolt required replacement.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 sep 2012 to oct 2012.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.No containment or corrective actions are recommended at this time.
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