(b)(4).One mis single inner set screw was returned to the complaints handling unit (chu) for evaluation.Visual examination of the mis single-inner set screw revealed signs of operative use as evidenced by superficial markings, with threads and drive feature slightly worn.It was noted that the rod striations were observed on the set screw suggesting that the set screw was seated properly.Unusual witness marks were noted on the surface of the screw as opposing to the general rod striations suggesting that the set screw might have loosened.A device history record review identified no issues that could have cause or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the loosening of the single-inner set screw cannot be determined.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.As such the complaint will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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