Corrected data: see e.1.Manufacturer narrative: the reason for this compliant was to report "the glenosphere removal tool we will not be getting back as it went to a lab for culture testing on an infected patient.The removal tool became stuck in the implant.The reamer we can send back.Possible time in service: 1.8 years.This event occurred post-operative near the patient.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instruments were inspected prior to surgery and found acceptable.It has been in excess of 84 days since the issuance of the rpr and the instrument has not been returned for investigation review as outlined in sales policy #4304.Section d.5.(of the attached product feedback form) indicates lost/discarded, however, the aforementioned reamer has not been returned.Instruments are subjected to heavy use/misuse/wear and care must be taken to avoid compromising their performance.Refer to the instrument ifu.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints for (b)(4): 1 functional, 3 dull/worn, 2 threads damaged/galled, 1 dimensional concern, 11 bent, 6 broke/cracked/damaged, 1 revision surgery, 1 end of life.Summary of complaints for (b)(4) : 1 functional.The root cause of this event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.
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