The reported firstpass suture device was returned for evaluation.A relationship between the device and reported incident was established as the device was received with its upper jaw broken off.From the information provided, the tip of the passer broke during surgery.Customers complaint was confirmed as our visual inspection shows the device was received with its upper jaw broken off and not received with the device.A needle was received loaded.Excessive damage was observed on the suture passer barrel.A full functional test cannot be performed on the device due to its received condition; however, the lever was able to actuate the attached needle.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force.Excessive force applied to the device can result in damage to the device.The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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