The reason for this compliant was to report the tip of the insertor broke off inside of the implant.This event occurred during surgery away from the patient.There was not another suitable device available, however, the incident did not cause a delay in surgery, surgery was completed as intended, and there was no risk or adverse event reported.The device was not made available to djo surgical for examination.The reported condition could possibly be a result of heavy use or misuse 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: 1 functional, 2 dull/worn, 6 threads damaged/galled, 3 broke/cracked/damaged.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.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.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.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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