The reported disposable firstpass suture passer, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established based on our visual observations.From the information provided, the teeth from top jaw broke off in 2 pieces and fell into patient.Visual evaluation shows the suture trap is broken off and the pieces have been returned.No other visual discrepancies.During functional evaluation the two step trigger performed as intended.The needle passed the suture through a piece of foam by using the index finger and depressing the trigger.Based on visual observations, customer¿s complaint was confirmed.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: excessive force.Incorrect suture used during the case.Insufficient retention of suture capture.Excessive force applied to the product or incorrect clinical suture used can result in product failure or damage to the product.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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