The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed with an open bracket.One half of the self-capturing is detached and was not returned with the device.There were no manufacturing abnormalities found on the device.During functional evaluation it was tried to activate the instrument.The needle can be deployed by pressing the levers; however the instrument is damaged and cannot be use as intended.The complaint was verified and the cause could not be defined with certainty.Factors that have nothing to do with the design and manufacture of the device and that may have contributed to the complaint event are described: excessive force should not be applied to the device and its levers when manipulating soft tissue, bones or hard objects.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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