It was reported that during an arcr procedure, when rotator cuff suturing, the tip of jaw could not open.Both handle and needle could not open.Back-up device was used.No patient injury, but 40 minutes delay was reported.
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The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed.The instrument was returned with an open bracket.There were no manufacturing abnormalities found on the device.During functional evaluation the two step trigger performed as intended.The bracket could be closed/opened as specified.The needle deploy through a om-3003 dome foam model by using the index finger and depressing the trigger.The self-capture is working as intended and the ultratape (cobraid blue 38¿)was successfully passed through as intended.The complaint was not verified and the root cause could not be defined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are (1) excessive force is be applied to the device when manipulating soft tissue, bone, 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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