It was reported that, during a shoulder surgery, the firstpass suture passer was faulty, it had both jaws closed and would not open.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other complications 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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The device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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