The returned device, intended for use in treatment, was returned for evaluation.There was no relationship found between the device and the reported incident.Visual inspection of the returned magnum2 knotless implant (b)(4) shows a deployed device.The implant is not detached and available undamaged at distal end.The suture lock button is not pressed down.There are no manufacturing abnormalities visually observed with the returned instrument.The suture lock button is not pressed down and in its original state.The magnum2 knotless is a single used device and cannot be functional tested.An attempt was made to test the basic functions of this instrument.Rotating the suture ratchet knob performed as intended.Pressing down the lock button with a single squeeze of the black hand-lever activates the bone lock and detaches the implant as specified.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle with the bone hole.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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