It was reported that the shoulder rotator cuff procedure, the jaw of the firstpass could not be opened and the trigger was abnormal.The procedure was completed by using a epidural needle and no significant delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.Do not use this device as a lever for manipulating hard tissue or bone.Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects.Misuse of this device may result in bent or broken distal tip or jaws.When passing suture multiple times always check the tip of the device for damage or debris between passes.Clear any visible debris between passes.Discontinue use if the device becomes damaged between passes.Tissue thickness may affect suture placement including stitch depth and needle entry point.Ensure adequate visibility when using the device.Should the needle tip become lodged (e.G., in bone), the needle should be disengaged by retracting it into the suture passer.Twisting or bending of the needle to dislodge the needle tip may result in breakage of the needle and needle parts may not be retrievable.Clinical evaluation was completed and concluded that based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed top bracket; the suture capture is in its original condition.During functional evaluation the first step of the trigger can be released but the bracket could not be opened; the device was dissected and a broken gear was found.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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