Manufacturer narrative: the reason for this complaint was a instrument failure reported as damage incurred from prolonged use and through misuse or rough handling of surgical instruments.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The device was returned to manufacturer and rma examination was completed.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows four prior complaints filed against the instrument's item number that reports a similar failure.No prior complaints report past instances of these instruments being affected by this failure.Review also shows no prior complaints against the instruments' lot number.The summary of complaints: 1 thread damaged & 3 bent.The root cause of this complaint is likely 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 systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported instrument was returned to djo and after further examination, shows that the tip of the rsp, head distractor is bent, confirming the complaint.The reported condition could possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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