There was a relationship found between the returned device and the reported event.Visual inspection for the device revealed the needle crescent broke off.No other visual discrepancies were found.Functional evaluation was not performed due to the broken condition of the returned device.Per information provided by the customer, the tip broke while passing through the tissue.Based on our visual investigation the reported event was confirmed; however, the root cause cannot be determined with confident.Factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Excessive force can result in failure.Tissue thickness may affect suture placement including stitch depth and needle entry point.The instruction for use (ifu) was reviewed and was 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 devices did not meet product specifications upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.
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