Correction: fda registration # to (b)(4).Section g1 manufacturing site updated to stryker spine-france method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the sales rep reported event was confirmed via visual inspection of returned device.The event resulted in a 20 minutes surgical delay and no adverse consequences to the patient.All broken fragments were retrieved.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Upon complaint history review and nc/capa history review, no relevant complaints/ nc/capa were identified.It was reported that anchor stopped advancing during insertion.After malleting a bit harder, an x-ray was taken showing the anchor had broken.Conclusion: the most likely cause of the reported event was determined to be user error- application of excessive insertion force by malleting the anchor.
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